| Level/ Type |
Code |
Display Name |
Code System |
Designations |
Description |
| 0‑L |
10100500
|
Concentrate for oral suspension
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation intended to be diluted in the specified liquid to obtain an oral
suspension.
|
| 0‑L |
10101000
|
Oral drops, solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid, usually multidose preparation consisting of a solution intended for oral use.
The preparation is administered in small volumes by means of a suitable measuring
device such as a dropper, pipette or oral syringe capable of accurate dosing of the
solution. The measured dose may be diluted in water or another suitable liquid before
swallowing.
|
| 0‑L |
10102000
|
Oral drops, suspension
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid, usually multidose preparation consisting of a suspension intended for oral
use. The preparation is administered in small volumes by means of a suitable measuring
device such as a dropper, pipette or oral syringe capable of accurate dosing of the
suspension. The measured dose may be diluted in water or another suitable liquid before
swallowing.
|
| 0‑L |
10103000
|
Oral drops, emulsion
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid, usually multidose preparation consisting of an emulsion intended for oral
use. The preparation is administered in small volumes by means of a suitable measuring
device such as a dropper, pipette or oral syringe capable of accurate dosing of the
emulsion. The measured dose may be diluted in water or another suitable liquid before
swallowing.
|
| 0‑L |
10104000
|
Oral liquid
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid single-dose or multidose preparation consisting of a liquid active substance
per se, intended for oral use. Each dose from a multidose container is administered
by means of a suitable device such as a measuring spoon.
|
| 0‑L |
10105000
|
Oral solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid single-dose or multidose preparation consisting of a solution intended for
oral use. Each dose from a multidose container is administered by means of a device
suitable for measuring the prescribed volume, generally 5 mL or multiples thereof.
|
| 0‑L |
10106000
|
Oral suspension
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid single-dose or multidose preparation consisting of a suspension intended for
oral use. Each dose from a multidose container is administered by means of a device
suitable for measuring the prescribed volume, generally 5 mL or multiples thereof.
|
| 0‑L |
10107000
|
Oral emulsion
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid single-dose or multidose preparation consisting of an emulsion intended for
oral use. Each dose from a multidose container is administered by means of a device
suitable for measuring the prescribed volume, generally 5 mL or multiples thereof.
|
| 0‑L |
10108000
|
Oral gel
|
0.4.0.127.0.16.1.1.2.1 |
|
Semi-solid single-dose or multidose preparation intended for oral use, consisting
of a gel, usually hydrophilic, to be swallowed after administration to the oral cavity.
|
| 0‑L |
10109000
|
Oral paste
|
0.4.0.127.0.16.1.1.2.1 |
|
Semi-solid single-dose or multidose preparation intended for oral use, consisting
of a paste to be swallowed after administration to the oral cavity.
|
| 0‑L |
10110000
|
Powder for oral solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of (a) solid active substance(s) which may also include
excipients to facilitate dissolution in the prescribed liquid. Powders for oral solution
include freeze-dried powders. The oral solution is usually prepared just before administration
to the patient.
|
| 0‑L |
10111000
|
Powder for oral suspension
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of (a) solid active substance(s) which may also include
excipients to facilitate dispersion in the prescribed liquid and to prevent sedimentation
during storage of the oral suspension. Powders for oral suspension include freeze-dried
powders. The oral suspension is usually prepared just before administration to the
patient.
|
| 0‑L |
10112000
|
Granules for oral solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of aggregated particles that may include excipients to
facilitate wetting and dissolution, intended to be dissolved in the specified liquid
to obtain an oral solution, which is usually prepared just before administration to
the patient.
|
| 0‑L |
10113000
|
Granules for oral suspension
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of aggregated particles that may include excipients to
facilitate wetting and dispersion, intended to be dispersed in the specified liquid
to obtain an oral suspension, which is usually prepared just before administration
to the patient.
|
| 0‑L |
10117000
|
Syrup
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid single-dose or multidose aqueous preparation characterised by a sweet taste
and a viscous consistency and usually containing aromatic or other flavouring agents,
intended for oral use. Each dose from a multidose container is administered by means
of a device suitable for measuring the prescribed volume, generally 5 mL or multiples
thereof.
|
| 0‑L |
10118000
|
Powder for syrup
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of one or more powders, including freeze-dried powders,
that may include excipients to facilitate dissolution in water and to obtain the characteristics
of a syrup, intended to be dissolved in water to obtain a syrup.
|
| 0‑L |
10119000
|
Granules for syrup
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of aggregated particles that may include excipients to
facilitate wetting and dissolution and to obtain the characteristics of a syrup, intended
to be dissolved in water to obtain a syrup.
|
| 0‑L |
10120000
|
Soluble tablet
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid single-dose preparation consisting of a tablet, usually uncoated, intended to
be dissolved in the specified liquid before being swallowed.
|
| 0‑L |
10121000
|
Dispersible tablet
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid single-dose preparation consisting of a tablet intended to be dispersed in the
specified liquid before being swallowed.
|
| 0‑L |
10121500
|
Dispersible tablets for dose dispenser
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of small, dispersible tablets that are designed to be
used in a dose dispenser, each tablet usually consisting of a small fraction of a
dose, with multiple tablets being automatically counted and administered as a single
dose.
|
| 0‑L |
10122000
|
Herbal tea
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting exclusively of one or more herbal drugs intended for
the preparation of an oral aqueous preparation by means of decoction, infusion or
maceration. Herbal teas are usually presented in bulk form or in bags. The tea is
prepared immediately before oral intake.
|
| 0‑L |
10201000
|
Oral powder
|
0.4.0.127.0.16.1.1.2.1 |
|
Single-dose or multidose preparation consisting of one or more particulate solids
of varying degrees of fineness. Oral powders are intended for oral administration.
They are generally administered in or with water or another suitable liquid, but may
also be swallowed directly.
|
| 0‑L |
10202000
|
Instant herbal tea
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of a lyophilised herbal drug extract intended to be dissolved
in water before oral use. Instant herbal teas are supplied in bulk form (multidose)
or in sachets (single-dose).
|
| 0‑L |
10203000
|
Effervescent powder
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid single-dose or multidose preparation consisting of one or more powders generally
containing acid substances and carbonates or hydrogen carbonates that react rapidly
in the presence of water to release carbon dioxide. Effervescent powders are intended
to be dissolved or dispersed in water before administration.
|
| 0‑L |
10204000
|
Granules
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid single-dose or multidose preparation consisting of solid, dry aggregates of
powder particles that are sufficiently resistant to withstand handling. Granules are
intended for oral use to release active substance(s) in the gastrointestinal fluids
by a rate depending essentially on the intrinsic properties of the active substance(s)
(conventional release).
They may be swallowed as such and/or chewed before swallowing, and some may also be
dissolved or dispersed in water or another suitable liquid before oral administration.
Granules for oral solution and Granules for oral suspension are excluded.
|
| 0‑L |
10205000
|
Effervescent granules
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid single-dose or multidose preparation consisting of uncoated granules generally
containing acidic substances and carbonates or hydrogen carbonates that rapidly react
in the presence of water to release carbon dioxide. Effervescent granules are intended
to be dissolved or dispersed in water before oral use.
|
| 0‑L |
10206000
|
Gastro-resistant granules
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of delayed-release granules intended to resist the gastric
fluid and release the active substance(s) in the intestinal fluid. This deliberate
modification is achieved by coating the granules with a gastro-resistant material
or by embedding the solid particles in the gastro-resistant material. Gastro-resistant
granules are usually
single-dose preparations intended for oral use.
|
| 0‑L |
10207000
|
Prolonged-release granules
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of granules showing a slower release than that of conventional-release
granules. This deliberate modification is achieved by a special formulation design
and/or manufacturing method. Prolonged-release granules are usually single-dose preparations
intended for oral use.
|
| 0‑L |
10208000
|
Modified-release granules
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of granules showing a rate and/or place of release different
from that of conventional-release granules. This deliberate modification is achieved
by a special formulation design and/or manufacturing method. Modified-release granules
are usually single-dose preparations intended for oral use, and include prolonged-release,
delayed
release and pulsatile-release granules. The generic term 'modified-release granules'
is used only when the more specific terms 'gastro-resistant granules' or 'prolonged-release
granules' do not apply.
|
| 0‑L |
10209000
|
Cachet
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid discoid preparation consisting of a wafer enclosing a unit dose intended for
oral use.
|
| 0‑L |
10210000
|
Capsule, hard
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid single-dose preparation contained in a hard shell, the capacity of which can
be varied. The shell is made of gelatin or other substances. It consists of two prefabricated
cylindrical sections one end of which is rounded and closed, the other being open.
The contents of the shell may be a solid or semi-solid preparation, which is filled
into one of the
sections and closed by slipping the other section over it. Hard capsules are intended
for oral use.
|
| 0‑L |
10211000
|
Capsule, soft
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid single-dose preparation contained in a soft shell, the capacity and shape of
which can be varied. The shell is made of gelatin or other substances and may contain
(a) solid active substance(s). The shell is thicker than that of hard capsules and
consists of one part as soft capsules usually are formed, filled and sealed in one
operation. The contents of
the shell may be a semi-solid or liquid preparation. Soft capsules are intended for
oral use.
|
| 0‑L |
10212000
|
Gastro-resistant capsule, hard
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid single-dose, delayed-release preparation contained in a hard shell. The preparation
is intended to resist the gastric fluid and to release the active substance(s) in
the intestinal fluid. Hard gastro-resistant capsules are usually made by filling hard
capsules with gastro-resistant granules or solid particles made gastro-resistant by
coating or, in
certain cases, by providing hard capsules with a gastro-resistant shell. They are
intended for oral use.
|
| 0‑L |
10213000
|
Gastro-resistant capsule, soft
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid single-dose, delayed-release preparation contained in a soft shell. The preparation
is intended to resist the gastric fluid and to release the active substance(s) in
the intestinal fluid. Soft gastro-resistant capsules are usually formed, filled and
sealed in one operation. They may contain a liquid or semi-solid preparation in the
gastro-resistant
shell. Soft gastro-resistant capsules are intended for oral use.
|
| 0‑L |
10214000
|
Chewable capsule, soft
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid single-dose preparation contained in a soft shell. The soft capsule is intended
to be chewed to release its contents into the mouth. The contents of the soft shell
may be a semi-solid or liquid preparation intended for local action or systemic delivery
after absorption through the oral mucosa or, when swallowed, in the gastrointestinal
tract.
|
| 0‑L |
10215000
|
Prolonged-release capsule, hard
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid single-dose preparation consisting of a hard shell containing a solid or semi-solid
formulation, showing a slower release of the active substance(s) than that of a conventional-release
capsule. Prolonged release is achieved by a special formulation design and/or manufacturing
method. Hard prolonged-release capsules are intended for oral use.
|
| 0‑L |
10216000
|
Prolonged-release capsule, soft
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid single-dose preparation consisting of a soft shell containing a semi-solid or
liquid formulation, showing a slower release of the active substance(s) than that
of a conventional-release capsule. Prolonged release is achieved by a special formulation
design and/or manufacturing method. Soft prolonged-release capsules are intended for
oral use.
|
| 0‑L |
10217000
|
Modified-release capsule, hard
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid single-dose preparation consisting of a hard shell containing a solid or semi-solid
formulation, showing a rate, a place and/or a time of release different from that
of a conventional-release capsule. This deliberate modification is achieved by a special
formulation design and/or manufacturing method. Hard modified-release capsules are
intended for oral
use, and include prolonged-release, delayed-release and pulsatile-release preparations.
The generic term 'modified-release capsule, hard' is used only when the more specific
terms 'gastro-resistant capsule, hard' or 'prolonged-release capsule, hard' do not
apply.
|
| 0‑L |
10218000
|
Modified-release capsule, soft
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid single-dose preparation consisting of a soft shell containing a semi-solid or
liquid formulation, showing a rate, a place and/or a time of release different from
that of a conventional-release capsule. This deliberate modification is achieved by
a special formulation design and/or manufacturing method. Soft modified-release capsules
are intended for
oral use, and include prolonged-release, delayed-release and pulsatile-release preparations.
The generic term 'modified-release capsule, soft' is used only when the more specific
terms 'gastro-resistant capsule, soft' or 'prolonged-release capsule, soft' do not
apply.
|
| 0‑L |
10219000
|
Tablet
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid single-dose uncoated preparation obtained by compressing uniform volumes of
particulate solids or by other means such as extrusion or moulding. Tablets include
single-layer tablets resulting from a single compression of particles and multi-layer
tablets consisting of concentric or parallel layers obtained by successive compressions
of particles of
different composition. Tablets are intended for oral use to release active substance(s)
in the gastrointestinal fluids by a rate depending essentially on the intrinsic properties
of active substance(s) (conventional release).
|
| 0‑L |
10220000
|
Coated tablet
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid single-dose preparation consisting of a tablet coated with one or more layers
of mixtures of various substances such as sugars and waxes. To the coating colouring
matter, flavouring substances and active substance(s) may be added. The thickness
of the coating is greater than that of a film-coated tablet. Coated tablets have a
smooth surface. They are
intended for oral use. When the coating dissolves or disintegrates the active substance(s)
is (are) released into the gastrointestinal fluid at a rate depending essentially
on its intrinsic properties (conventional release).
|
| 0‑L |
10221000
|
Film-coated tablet
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid single-dose preparation consisting of a tablet coated with a thin polymeric
film that dissolves within a few minutes in the gastrointestinal fluid. Film-coated
tablets are intended for oral use to release active substance(s) at a rate which is
not significantly delayed compared to that of the uncoated tablet.
|
| 0‑L |
10222000
|
Effervescent tablet
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid single-dose preparation consisting of an uncoated tablet generally containing
acid substances and carbonates or hydrogen carbonates, which react rapidly in the
presence of water to release carbon dioxide. Effervescent tablets are intended to
be dissolved or dispersed in water before oral use.
|
| 0‑L |
10223000
|
Orodispersible tablet
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid single-dose preparation consisting of an uncoated tablet intended to be placed
in the mouth where it disperses rapidly in saliva before being swallowed.
|
| 0‑L |
10224000
|
Oral lyophilisate
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid single-dose preparation made by freeze-drying of a liquid or semi-solid preparation.
This fast-releasing preparation is intended to be placed in the mouth where its contents
are released in saliva and swallowed or, alternatively, to be dissolved in water before
oral administration.
|
| 0‑L |
10225000
|
Gastro-resistant tablet
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid single-dose, delayed-release tablet intended to resist the gastric fluid and
to release the active substance(s) in the intestinal fluid. These properties are achieved
by coating the tablet with a gastro-resistant material or by embedding solid particles
in the gastro-resistant material before compression. Gastro-resistant tablets are
intended for oral
administration.
|
| 0‑L |
10226000
|
Prolonged-release tablet
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid single-dose preparation consisting of a tablet showing a slower release of the
active substance(s) than that of a conventional-release tablet. Prolonged release
is achieved by a special formulation design and/or manufacturing method. Prolonged-release
tablets are intended for oral use.
|
| 0‑L |
10227000
|
Modified-release tablet
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid single-dose preparation consisting of a tablet showing a rate, a place and/or
a time of release different from that of a conventional-release tablet. This deliberate
modification is achieved by a special formulation design and/or manufacturing method.
Modified-release tablets are intended for oral use, and include prolonged-release,
delayed-release and
pulsatile-release preparations. The generic term 'modified-release tablet' is used
only when the more specific terms 'gastro-resistant tablet' or 'prolonged-release
tablet' do not apply.
|
| 0‑L |
10228000
|
Chewable tablet
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid single-dose preparation consisting of an uncoated tablet intended to be chewed
before being swallowed. Chewable tablets are intended for oral administration.
|
| 0‑L |
10229000
|
Medicated chewing-gum
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid single-dose preparation consisting of a basis, mainly composed of gums, intended
to be chewed but not swallowed. The active substance(s) is (are) released in saliva
by chewing. Medicated chewing gum is intended for local treatment of mouth diseases
or systemic delivery after absorption through the oral mucosa or from the gastrointestinal
tract.
|
| 0‑L |
10230000
|
Oral gum
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid single-dose preparation with a gum-like consistency, intended to be sucked or
chewed before being swallowed. Medicated chewing gum is excluded.
|
| 0‑L |
10231000
|
Pillules
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation for homoeopathic use, obtained from sucrose, lactose or other suitable
excipients. Pillules may be prepared by impregnation of preformed pillules with a
dilution or dilutions of homoeopathic stocks or by progressive addition of these excipients
and the addition of a dilution or dilutions of homoeopathic stocks. Pillules are intended
for oral
or sublingual use.
|
| 0‑L |
10236100
|
Orodispersible film
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of a single- or multilayer sheet of suitable material(s)
intended to be placed in the mouth where it disperses rapidly before being swallowed.
|
| 0‑L |
10301000
|
Gargle
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation consisting of an aqueous solution intended for gargling to obtain
a local effect in the oral cavity and the throat. Gargles are not to be swallowed.
|
| 0‑L |
10302000
|
Concentrate for gargle
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation consisting of an aqueous solution intended to be diluted in water
to obtain a gargle.
|
| 0‑L |
10303000
|
Gargle, powder for solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of one or more powders intended to be dissolved in water
to obtain a gargle.
|
| 0‑L |
10304000
|
Gargle, tablet for solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of a tablet intended to be dissolved in water to obtain
a gargle.
|
| 0‑L |
10305000
|
Oromucosal solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid single-dose or multidose preparation consisting of a solution intended for
oromucosal use.
|
| 0‑L |
10306000
|
Oromucosal suspension
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid single-dose or multidose preparation consisting of a suspension intended for
oromucosal use.
|
| 0‑L |
10307000
|
Oromucosal drops
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid, usually multidose preparation consisting of a solution, suspension or emulsion
intended for oromucosal use. Oromucosal drops are administered by instillation into
the oral cavity or onto a specific part of the oral cavity.
|
| 0‑L |
10308100
|
Oromucosal spray, emulsion
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid, usually multidose preparation consisting of an emulsion intended for oromucosal
use. It is administered by spraying into the oral cavity or onto a specific part of
the oral cavity or the throat. It is presented in a container with a spray pump or
in a pressurised container with or without a metering valve. Sublingual sprays are
excluded.
|
| 0‑L |
10308200
|
Oromucosal spray, solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid, usually multidose preparation consisting of a solution intended for oromucosal
use. It is administered by spraying into the oral cavity or onto a specific part of
the oral cavity or the throat. It is presented in a container with a spray pump or
in a pressurised container with or without a metering valve. Sublingual sprays are
excluded.
|
| 0‑L |
10308300
|
Oromucosal spray, suspension
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid, usually multidose preparation consisting of a suspension intended for oromucosal
use. It is administered by spraying into the oral cavity or onto a specific part of
the oral cavity or the throat. It is presented in a container with a spray pump or
in a pressurised container with or without a metering valve. Sublingual sprays are
excluded.
|
| 0‑L |
10309100
|
Sublingual spray, emulsion
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid, usually multidose preparation consisting of an emulsion intended for sublingual
use. Sublingual sprays are usually presented in pressurised containers with a metering
valve.
|
| 0‑L |
10309200
|
Sublingual spray, solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid, usually multidose preparation consisting of a solution intended for sublingual
use. Sublingual sprays are usually presented in pressurised containers with a metering
valve.
|
| 0‑L |
10309300
|
Sublingual spray, suspension
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid, usually multidose preparation consisting of a suspension intended for sublingual
use. Sublingual sprays are usually presented in pressurised containers with a metering
valve.
|
| 0‑L |
10310000
|
Mouthwash
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation consisting of an aqueous solution intended for use in contact with
the oral mucosa. It is not to be swallowed. Mouthwashes may contain excipients to
adjust the pH which as far as possible is neutral.
|
| 0‑L |
10311000
|
Mouthwash, tablet for solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of an uncoated tablet intended to be dissolved in water
to obtain a mouthwash.
|
| 0‑L |
10312000
|
Gingival solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid, usually multidose preparation consisting of a solution intended for gingival
use.
|
| 0‑L |
10313000
|
Oromucosal gel
|
0.4.0.127.0.16.1.1.2.1 |
|
Semi-solid single-dose or multidose preparation consisting of a hydrophilic gel intended
for oromucosal use. It is applied to the oral cavity or onto a specific part of the
oral cavity, to obtain a local effect. Gingival gel is excluded.
|
| 0‑L |
10314000
|
Oromucosal paste
|
0.4.0.127.0.16.1.1.2.1 |
|
Semi-solid single-dose or multidose preparation consisting of a paste of solid particles
finely dispersed in a hydrophilic basis intended for oromucosal use. Oromucosal pastes
are applied to the oral cavity or onto a specific part of the oral cavity, to obtain
a local effect. Gingival paste is excluded.
|
| 0‑L |
10314005
|
Oromucosal ointment
|
0.4.0.127.0.16.1.1.2.1 |
|
Semi-solid multidose preparation consisting of an ointment intended for oromucosal
use. It is applied to the oral cavity or onto a specific part of the oral cavity,
to obtain a local effect
|
| 0‑L |
10314010
|
Oromucosal cream
|
0.4.0.127.0.16.1.1.2.1 |
|
Semi-solid, usually multidose preparation consisting of an oil-in-water emulsion intended
for oromucosal use. Oromucosal creams are applied to the oral cavity or onto a specific
part of the oral cavity, other than the gingivae, to obtain a local effect.
|
| 0‑L |
10314011
|
Buccal film
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of a single- or multilayer sheet of suitable material(s)
intended to be applied to the buccal cavity (pouch) to obtain a systemic effect.
|
| 0‑L |
10315000
|
Gingival gel
|
0.4.0.127.0.16.1.1.2.1 |
|
Semi-solid single-dose or multidose preparation consisting of a gel intended for gingival
use to obtain a local effect.
|
| 0‑L |
10316000
|
Gingival paste
|
0.4.0.127.0.16.1.1.2.1 |
|
Semi-solid single-dose or multidose preparation consisting of a paste of solid particles
finely dispersed in a hydrophilic basis intended for gingival use to obtain a local
effect.
|
| 0‑L |
10317000
|
Oromucosal capsule
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid single-dose preparation contained in a soft shell to be chewed or sucked to
obtain a local effect in the oral cavity.
|
| 0‑L |
10317500
|
Sublingual film
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of a single- or multilayer sheet of suitable material(s)
intended for sublingual use to obtain a systemic effect.
|
| 0‑L |
10318000
|
Sublingual tablet
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid single-dose preparation consisting of an uncoated tablet intended for sublingual
use. Sublingual tablets are usually prepared by compression of mixtures of powders
or granulations into tablets with a shape suited for the intended use. Other technologies
such as moulding may be used.
|
| 0‑L |
10319000
|
Muco-adhesive buccal tablet
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid single-dose preparation to be applied to the buccal mucosa to obtain a systemic
delivery over an extended period of time. Mucoadhesive buccal tablets are usually
prepared by compression of mixtures of powders or granulations into tablets with a
shape suited for the intended use. They usually contain hydrophilic polymers, which
on wetting with saliva
produce a flexible hydrogel that adheres to the buccal mucosa.
|
| 0‑L |
10320000
|
Buccal tablet
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid single-dose preparation to be applied to the buccal cavity (pouch) to obtain
systemic delivery. Buccal tablets are prepared by compression of mixtures of powders
or granulations into tablets with a shape suited for the intended use.
|
| 0‑L |
10321000
|
Lozenge
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid single-dose preparation intended to be sucked to obtain, usually, a local effect
in the oral cavity and the throat. Lozenges are hard preparations prepared by moulding.
They usually contain flavouring and sweetening agents. Lozenges dissolve or disintegrate
slowly when sucked.
|
| 0‑L |
10322000
|
Compressed lozenge
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid single-dose preparation intended to be sucked to obtain a local or systemic
effect. It is prepared by compression and is often rhomboid in shape. Compressed lozenges
usually contain flavouring and sweetening agents. They dissolve or disintegrate slowly
when sucked.
|
| 0‑L |
10323000
|
Pastille
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid single-dose preparation intended to be sucked to obtain, usually, a local effect
in the oral cavity and the throat. Pastilles are soft, flexible preparations prepared
by moulding of mixtures containing natural or synthetic polymers or gums and sweeteners.
They dissolve or disintegrate slowly when sucked.
|
| 0‑L |
10401000
|
Periodontal powder
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of one or more powders intended for administration within
the tooth socket/periodontal membrane.
|
| 0‑L |
10401500
|
Dental cement
|
0.4.0.127.0.16.1.1.2.1 |
|
Semi-solid preparation intended for application in or on teeth, which subsequently
hardens to form a seal or bond.
|
| 0‑L |
10402000
|
Dental gel
|
0.4.0.127.0.16.1.1.2.1 |
|
Semi-solid, usually multidose preparation consisting of a hydrophilic gel intended
for administration on teeth and gums by rubbing.
|
| 0‑L |
10403000
|
Dental stick
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid single-dose preparation, rod-shaped and usually prepared by compression or moulding,
intended for dental use.
|
| 0‑L |
10405000
|
Dental powder
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of one or more powders intended for administration on
teeth and gums.
|
| 0‑L |
10406000
|
Dental solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid, usually multidose preparation consisting of a solution intended for administration
on teeth and gums.
|
| 0‑L |
10407000
|
Dental suspension
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid, usually multidose preparation consisting of a suspension intended for administration
on teeth and gums.
|
| 0‑L |
10408000
|
Dental emulsion
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid, usually multidose preparation consisting of an emulsion intended for administration
on to the teeth and the gums.
|
| 0‑L |
10409000
|
Toothpaste
|
0.4.0.127.0.16.1.1.2.1 |
|
Semi-solid, usually multidose preparation consisting of a hydrophilic paste intended
to be rubbed onto the teeth.
|
| 0‑L |
10410000
|
Periodontal gel
|
0.4.0.127.0.16.1.1.2.1 |
|
Semi-solid preparation consisting of a gel intended to be placed in the pouch between
the tooth and the gingiva.
|
| 0‑L |
10411000
|
Periodontal insert
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid single-dose preparation consisting of a medicated insert to be placed within
the tooth socket/periodontal membrane. The biodegradable insert is a sheet which slowly
releases active substance(s).
|
| 0‑L |
10413000
|
Powder for dental cement
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of one or more powders, including freeze-dried powders,
intended for use in the preparation of a dental cement.
|
| 0‑L |
10414000
|
Solution for dental cement
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation consisting of a solution intended for use in the preparation of
a dental cement.
|
| 0‑L |
10501000
|
Bath additive
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid, semi-solid or liquid preparation to be added to the bath water. |
| 0‑L |
10502000
|
Cream
|
0.4.0.127.0.16.1.1.2.1 |
|
Semi-solid single-dose or multidose preparation of homogeneous appearance consisting
of a lipophilic phase and an aqueous phase, one of which is finely dispersed in the
other. Active substance(s) are dissolved or dispersed in the basis, which may be hydrophilic
or hydrophobic. Creams are intended for cutaneous use. In certain cases, transdermal
delivery may
be obtained.
|
| 0‑L |
10503000
|
Gel
|
0.4.0.127.0.16.1.1.2.1 |
|
Semi-solid single-dose or multidose preparation consisting of a single-phase basis
of liquids gelled by a suitable gelling agent, intended for cutaneous use. Active
substance(s) are dissolved or dispersed in the basis, which may be hydrophilic or
hydrophobic.
|
| 0‑L |
10504000
|
Ointment
|
0.4.0.127.0.16.1.1.2.1 |
|
Semi-solid single-dose or multidose preparation consisting of a single-phase basis
in which solids or liquids may be dispersed. Active substance(s) are dissolved or
dispersed in the basis, which may be hydrophilic, hydrophobic or water-emulsifying.
Ointments are intended for cutaneous use. In certain cases, transdermal delivery may
be obtained.
|
| 0‑L |
10505000
|
Cutaneous paste
|
0.4.0.127.0.16.1.1.2.1 |
|
Semi-solid single-dose or multidose preparation containing a large proportion of finely
divided solids dispersed in the basis, intended for cutaneous use.
|
| 0‑L |
10506000
|
Medicated plaster
|
0.4.0.127.0.16.1.1.2.1 |
|
Flexible single-dose preparation intended to be applied to the skin to obtain, usually,
a local effect. Medicated plasters consist of an adhesive basis containing the active
substance and spread as a uniform layer on an appropriate support made of natural
or synthetic material. The adhesive layer is covered by a suitable protective liner,
which is removed
before applying the plaster to the skin. Medicated plasters are presented in a range
of sizes or as larger sheets to be cut before use.
|
| 0‑L |
10507000
|
Cutaneous foam
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid, usually multidose preparation, usually presented in a pressurised container
equipped with an applicator suitable for delivery of a foam consisting of large volumes
of gas dispersed in a liquid containing active substance(s). Cutaneous foams are intended
for cutaneous use.
|
| 0‑L |
10508000
|
Shampoo
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid or, occasionally, semi-solid, usually multidose preparation intended for application
to the scalp by rubbing and subsequent washing away with water. Upon rubbing with
water, shampoos usually form foam. Shampoos are solutions, suspensions or emulsions
containing surface-active agents.
|
| 0‑L |
10509000
|
Cutaneous spray, solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation, usually multidose, consisting of a solution in a pressurised container
with a spray valve or in a container equipped with a spray pump, intended for cutaneous
use.
|
| 0‑L |
10510000
|
Cutaneous spray, suspension
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid, usually multidose preparation consisting of a suspension in a pressurised
container with a spray valve or in a container equipped with a spray pump, intended
for cutaneous use.
|
| 0‑L |
10511000
|
Cutaneous spray, powder
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid, usually multidose preparation presented in a pressurised container with a spray
valve or in a container equipped with a spray pump. The spray is intended for cutaneous
use.
|
| 0‑L |
10512000
|
Cutaneous liquid
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid, usually multidose preparation consisting of a liquid active substance per
se, intended for cutaneous use.
|
| 0‑L |
10513000
|
Cutaneous solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid, usually multidose preparation consisting of a solution of the active substance
in a suitable vehicle intended for cutaneous use.
|
| 0‑L |
10514000
|
Concentrate for cutaneous solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation intended to be diluted in the specified liquid to obtain a cutaneous
solution.
|
| 0‑L |
10514500
|
Powder for cutaneous solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of one or more powders, including freeze-dried powders,
intended to be dissolved in the specified liquid to obtain a cutaneous solution.
|
| 0‑L |
10515000
|
Cutaneous suspension
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid, usually multidose preparation consisting of a suspension of fine particles
in a suitable vehicle intended for cutaneous use.
|
| 0‑L |
10516000
|
Cutaneous emulsion
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid, usually multidose preparation consisting of an emulsion intended for cutaneous
use.
|
| 0‑L |
10517000
|
Cutaneous powder
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid, usually multidose preparation consisting of a powder intended for cutaneous
use. Cutaneous spray, powder is excluded.
|
| 0‑L |
10517500
|
Cutaneous patch
|
0.4.0.127.0.16.1.1.2.1 |
|
Flexible single-dose preparation intended to be applied to the unbroken skin to obtain
a local effect by penetration of the active substance(s) into the skin.
|
| 0‑L |
10518000
|
Solution for iontophoresis
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation consisting of an aqueous solution intended for transdermal delivery
by means of iontophoresis.
|
| 0‑L |
10518500
|
Powder for solution for iontophoresis
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of one or more powders, including freeze-dried powders,
intended to be dissolved in the specified liquid to obtain a solution for iontophoresis.
|
| 0‑L |
10519000
|
Transdermal patch
|
0.4.0.127.0.16.1.1.2.1 |
|
Flexible single-dose preparation intended to be applied to the unbroken skin to obtain
a systemic delivery over an extended period of time. Transdermal patches consist of
a backing sheet supporting a reservoir or a matrix containing the active substance(s)
and on the top a pressure-sensitive adhesive, which assures the adhesion of the preparation
to the skin.
The backing sheet is impermeable to the active substance(s) and normally impermeable
to water. In reservoir systems the active substance may be dissolved or dispersed
in a semi-solid basis or in a solid polymer matrix, which is separated from the skin
by a rate-controlling membrane. The pressure-sensitive adhesive may, in this case,
be applied to some or all parts of the
membrane, or only around the border of the membrane and the backing sheet. Matrix
systems contain the active substance in a solid or semi-solid matrix, the properties
of which control the diffusion pattern to the skin. The matrix system may also be
a solution or dispersion of the active substance in the pressure-sensitive adhesive.
The releasing surface of the patch is covered
by a protective liner to be removed before applying the patch to the skin.
|
| 0‑L |
10520000
|
Collodion
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation usually containing pyroxylin in a mixture of ether and ethanol.
When applied to the skin, the preparation forms a flexible film on the site of application.
|
| 0‑L |
10521000
|
Medicated nail lacquer
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation to be applied to the nails to form a lacquer by evaporation of
the volatile solvent.
|
| 0‑L |
10522000
|
Poultice
|
0.4.0.127.0.16.1.1.2.1 |
|
Semi-solid preparation consisting of a hydrophilic heat-retentive basis in which solid
or liquid active substance(s) are dispersed, usually intended to be spread thickly
on a suitable dressing and heated before application to the skin.
|
| 0‑L |
10523000
|
Cutaneous stick
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation, usually rod-shaped or conical, intended for application to the
skin to obtain a local effect. Cutaneous sticks may consist of the active substance(s)
alone or dissolved or dispersed in a suitable basis.
|
| 0‑L |
10525000
|
Impregnated dressing
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of a piece or strip of gauze or other suitable fabric
impregnated with a liquid or semi-solid preparation intended for cutaneous use.
|
| 0‑L |
10546250
|
Transdermal gel
|
0.4.0.127.0.16.1.1.2.1 |
|
Semi-solid single-dose or multidose preparation consisting of a single-phase basis
of liquids gelled by a suitable gelling agent. Active substance(s) is (are) dissolved
or dispersed in the basis, which may be hydrophilic or hydrophobic. Transdermal gels
are intended for transdermal use.
|
| 0‑L |
10546400
|
Transdermal solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid single-dose or multidose preparation consisting of a solution intended for
transdermal use. The term 'Transdermal solution' is used only when more-specific terms
such as 'Pour-on solution', 'Solution for iontophoresis', 'Spot-on solution' and 'Transdermal
spray, solution' do not apply.
|
| 0‑L |
10546500
|
Transdermal spray, solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid, usually multidose preparation consisting of a solution in a pressurised container
with a spray valve or a container equipped with a spray pump, intended for transdermal
use.
|
| 0‑L |
10547000
|
Transdermal system
|
0.4.0.127.0.16.1.1.2.1 |
|
Assembly of components intended for transdermal delivery driven by external forces
(e.g. electric current, chemical reaction,...). Transdermal patch is excluded.
|
| 0‑L |
10548000
|
Solution for skin-prick test
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile preparation consisting of a solution containing an allergen product
intended for diagnostic use in a skin-prick test.
|
| 0‑L |
10549000
|
Solution for skin-scratch test
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile preparation consisting of a solution containing an allergen product
intended for diagnostic use in a skin-scratch test.
|
| 0‑L |
10550000
|
Plaster for provocation test
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid flexible preparation containing an allergen product intended for provocation
testing by application to the skin.
|
| 0‑L |
10600500
|
Concentrate for solution for intraocular irrigation
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile preparation intended to be diluted in the specified liquid to obtain
a solution for intraocular irrigation.
|
| 0‑L |
10601000
|
Eye cream
|
0.4.0.127.0.16.1.1.2.1 |
|
Semi-solid sterile single-dose or multidose preparation consisting of a cream intended
for ocular use. Eye creams may be presented in collapsible tubes fitted with a cannula
and having a content of not more than 5 g of the preparation. Eye creams may also
be presented in suitably designed single-dose containers. The containers or nozzles
of tubes are of a
shape that facilitates administration without contamination.
|
| 0‑L |
10602000
|
Eye gel
|
0.4.0.127.0.16.1.1.2.1 |
|
Semi-solid sterile single-dose or multidose preparation consisting of a gel intended
for ocular use. Eye gels may be presented in collapsible tubes fitted with a cannula
and having a content of not more than 5 g of the preparation. Eye gels may also be
presented in suitably designed single-dose containers. The containers or nozzles of
tubes are of a shape
that facilitates administration without contamination.
|
| 0‑L |
10603000
|
Eye ointment
|
0.4.0.127.0.16.1.1.2.1 |
|
Semi-solid sterile single-dose or multidose preparation consisting of an ointment
intended for ocular use. Eye ointments may be presented in collapsible tubes fitted
with a cannula and having a content of not more than 5 g of the preparation. Eye ointments
may also be presented in suitably designed single-dose containers. The containers
or nozzles of tubes
are of a shape that facilitates administration without contamination.
|
| 0‑L |
10604000
|
Eye drops, solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile single-dose or multidose preparation consisting of an aqueous or oily
solution intended for ocular use. Multidose preparations are presented in containers
that allow successive drops to be administered. The containers contain usually at
most 10 mL of the preparation.
|
| 0‑L |
10604500
|
Eye drops, emulsion
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile single-dose or multidose preparation consisting of an emulsion intended
for ocular use. Multidose preparations are presented in containers that allow successive
drops to be administered. The containers contain usually at most 10 mL of the preparation.
|
| 0‑L |
10605000
|
Eye drops, suspension
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile single-dose or multidose preparation consisting of an aqueous or oily
suspension intended for ocular use. Multidose preparations are presented in containers
that allow successive drops to be administered. The containers contain usually at
most 10 mL of the preparation.
|
| 0‑L |
10608000
|
Eye drops, solvent for reconstitution
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation consisting of a sterile solvent containing no active substances,
intended for reconstitution of a usually freeze-dried powder for eye drops.
|
| 0‑L |
10609000
|
Eye drops, prolonged-release
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile single-dose or multidose preparation intended for ocular use. The active
substance is released over an extended period of time.
|
| 0‑L |
10610000
|
Eye lotion
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile single-dose or multidose preparation consisting of an aqueous solution
intended for washing or bathing the eye.
|
| 0‑L |
10611000
|
Eye lotion, solvent for reconstitution
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation consisting of a sterile solvent containing no active substances,
intended for reconstitution of a usually freeze-dried powder for eye lotion.
|
| 0‑L |
10612000
|
Ophthalmic insert
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid sterile preparation of suitable size and shape, designed to be inserted in the
conjunctival sac to produce a local or ocular effect by the release of active substance(s)
over a determined period of time. Ophthalmic inserts generally consist of a reservoir
of active substance(s) embedded in a matrix or bounded by a rate-controlling membrane.
They are
presented individually in sterile containers.
|
| 0‑L |
10613000
|
Ophthalmic strip
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid sterile single-dose preparation consisting of a strip made of a suitable material
usually impregnated with active substance(s) intended for use on the eyeball.
|
| 0‑L |
10701000
|
Ear cream
|
0.4.0.127.0.16.1.1.2.1 |
|
Semi-solid single-dose or multidose preparation consisting of a cream intended for
application to the external auditory meatus, if necessary by means of a tampon impregnated
with the preparation.
|
| 0‑L |
10702000
|
Ear gel
|
0.4.0.127.0.16.1.1.2.1 |
|
Semi-solid single-dose or multidose preparation consisting of a gel intended for application
to the external auditory meatus, if necessary by means of a tampon impregnated with
the preparation.
|
| 0‑L |
10703000
|
Ear ointment
|
0.4.0.127.0.16.1.1.2.1 |
|
Semi-solid single-dose or multidose preparation consisting of an ointment intended
for application to the external auditory meatus, if necessary by means of a tampon
impregnated with the preparation.
|
| 0‑L |
10704000
|
Ear drops, solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid single-dose or multidose preparation consisting of an aqueous or oily solution
intended for application to the external auditory meatus. Multidose containers may
be dropper containers or containers provided with a dropper applicator, or the dropper
may be supplied separately. Drops are not necessarily administered dropwise, but may
also be administered
as a small volume.
|
| 0‑L |
10705000
|
Ear drops, suspension
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid single-dose or multidose preparation consisting of an aqueous or oily suspension
intended for application to the external auditory meatus. Multidose containers may
be dropper containers or containers provided with a dropper applicator, or the dropper
may be supplied separately. Drops are not necessarily administered dropwise, but may
also be
administered as a small volume.
|
| 0‑L |
10706000
|
Ear drops, emulsion
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid single-dose or multidose preparation consisting of an emulsion intended for
application to the external auditory meatus. Multidose containers may be dropper containers
or containers provided with a dropper applicator, or the dropper may be supplied separately.
Drops are not necessarily administered dropwise, but may also be administered as a
small
volume.
|
| 0‑L |
10708000
|
Ear powder
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid, usually multidose preparation consisting of one or more powders consisting
of (a) solid active substance(s) intended for application to the external auditory
meatus. Ear powders are presented in containers fitted with a suitable applicator
or device for insufflation.
|
| 0‑L |
10709000
|
Ear spray, solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid, usually multidose preparation consisting of a solution intended for application
to the external auditory meatus by spraying to obtain a local effect. Ear sprays are
presented in containers with a spray pump or in pressurised containers fitted with
a spray valve.
|
| 0‑L |
10710000
|
Ear spray, suspension
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid, usually multidose preparation consisting of a suspension intended for application
to the external auditory meatus by spraying to obtain a local effect. Ear sprays are
presented in containers with a spray pump or in pressurised containers fitted with
a spray valve.
|
| 0‑L |
10711000
|
Ear spray, emulsion
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid, usually multidose preparation consisting of an emulsion intended for application
to the external auditory meatus by spraying to obtain local effect. Ear sprays are
presented in containers with a spray pump or in pressurised containers fitted with
a spray valve.
|
| 0‑L |
10712000
|
Ear wash, solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid single-dose or multidose preparation consisting usually of an aqueous solution
with a pH within physiological limits. Ear washes are intended to clean the external
auditory meatus.
|
| 0‑L |
10713000
|
Ear wash, emulsion
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid single-dose or multidose preparation consisting usually of an oil-in-water
emulsion with a pH within physiological limits. Ear washes are intended to clean the
external auditory meatus.
|
| 0‑L |
10714000
|
Ear tampon
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid single-dose preparation intended to be inserted into the external auditory meatus
for a limited period of time, consisting of a suitable material impregnated with active
substance(s).
|
| 0‑L |
10715000
|
Ear stick
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid single-dose preparation of usually conical shape intended to be inserted in
the external auditory meatus where it melts or dissolves.
|
| 0‑L |
10801000
|
Nasal cream
|
0.4.0.127.0.16.1.1.2.1 |
|
Semi-solid single-dose or multidose preparation consisting of a cream, usually of
oil-in-water type, intended for nasal use to obtain a local effect. Nasal creams are
usually presented in tubes fitted with a nasal applicator.
|
| 0‑L |
10802000
|
Nasal gel
|
0.4.0.127.0.16.1.1.2.1 |
|
Semi-solid single-dose or multidose preparation consisting of usually a hydrophilic
gel, intended for nasal use to obtain a local effect. Nasal gels are usually presented
in tubes fitted with a nasal applicator.
|
| 0‑L |
10803000
|
Nasal ointment
|
0.4.0.127.0.16.1.1.2.1 |
|
Semi-solid single-dose or multidose preparation consisting of an ointment, intended
for nasal use to obtain a local effect. Nasal ointments are usually presented in tubes
fitted with a nasal applicator.
|
| 0‑L |
10804000
|
Nasal drops, solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid single-dose or multidose preparation consisting of a solution intended for
nasal use by means of a suitable applicator.
|
| 0‑L |
10805000
|
Nasal drops, suspension
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid single-dose or multidose preparation consisting of a suspension intended for
nasal use by means of a suitable applicator.
|
| 0‑L |
10806000
|
Nasal drops, emulsion
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid single-dose or multidose preparation consisting of an emulsion intended for
nasal use by means of a suitable applicator.
|
| 0‑L |
10807000
|
Nasal powder
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid, usually multidose preparation consisting of one or more powders of solid active
substance(s) intended for nasal use by insufflation into the nasal cavity.
|
| 0‑L |
10808000
|
Nasal spray, solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid single-dose or multidose preparation consisting of a solution in a container
with or without a metering dose valve or in a container with a spray pump or equivalent
device to create a spray, intended for nasal use.
|
| 0‑L |
10809000
|
Nasal spray, suspension
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid single-dose or multidose preparation consisting of a suspension in a container
with or without a metering dose valve or in a container with a spray pump or equivalent
device to create a spray, intended for nasal use.
|
| 0‑L |
10810000
|
Nasal spray, emulsion
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid single-dose or multidose preparation consisting of an emulsion in a container
with or without a metering dose valve or in a container with a spray pump or equivalent
device to create a spray, intended for nasal use.
|
| 0‑L |
10811000
|
Nasal wash
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid single-dose or multidose preparation consisting of usually an aqueous isotonic
solution intended for cleansing the nasal cavities.
|
| 0‑L |
10812000
|
Nasal stick
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid single-dose preparation, usually rod-shaped or conical, intended for nasal use
to obtain a local effect.
|
| 0‑L |
10901000
|
Vaginal cream
|
0.4.0.127.0.16.1.1.2.1 |
|
Semi-solid preparation consisting of a cream usually presented in a single-dose container
provided with a suitable applicator, intended for vaginal use to obtain a local effect.
|
| 0‑L |
10902000
|
Vaginal gel
|
0.4.0.127.0.16.1.1.2.1 |
|
Semi-solid preparation consisting of a gel usually presented in a single-dose container
provided with a suitable applicator, intended for vaginal use to obtain a local effect.
|
| 0‑L |
10903000
|
Vaginal ointment
|
0.4.0.127.0.16.1.1.2.1 |
|
Semi-solid preparation consisting of an ointment usually presented in a single-dose
container provided with a suitable applicator, intended for vaginal use to obtain
a local effect.
|
| 0‑L |
10904000
|
Vaginal foam
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation, usually presented in a pressurised container provided with an
applicator suitable for delivery to the vagina of foam containing large volumes of
gas dispersed in a liquid containing active substance(s). Vaginal foams are intended
for vaginal use, for example for contraception.
|
| 0‑L |
10905000
|
Vaginal solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation consisting of a solution intended for vaginal use by means of a
suitable applicator in order to obtain a local effect.
|
| 0‑L |
10906000
|
Vaginal suspension
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation consisting of a suspension intended for vaginal use by means of
a suitable applicator in order to obtain a local effect.
|
| 0‑L |
10907000
|
Vaginal emulsion
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation consisting of an emulsion intended for vaginal use by means of
a suitable applicator in order to obtain a local effect.
|
| 0‑L |
10908000
|
Tablet for vaginal solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid, usually single-dose preparation consisting of a tablet, usually uncoated, intended
to be dissolved in the specified liquid to obtain a vaginal solution.
|
| 0‑L |
10909000
|
Pessary
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid, single-dose preparation usually prepared by moulding, of various shapes, usually
ovoid, with a volume and consistency suitable for insertion into the vagina to obtain
a local effect. It contains one or more active substances dispersed or dissolved in
a suitable basis that may be soluble or dispersible in water or may melt at body temperature.
|
| 0‑L |
10910000
|
Vaginal capsule, hard
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid single-dose preparation consisting of a hard capsule of a size and shape suited
for vaginal use, containing a liquid or semi-solid formulation, intended for a local
effect.
|
| 0‑L |
10911000
|
Vaginal capsule, soft
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid single-dose preparation consisting of a soft capsule of a size and shape suited
for vaginal use, containing a liquid or semi-solid formulation, intended for a local
effect.
|
| 0‑L |
10912000
|
Vaginal tablet
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid single-dose preparation consisting of a tablet, usually uncoated or film-coated,
intended for administration to the vagina to obtain a local effect. Vaginal tablets
are usually of larger size and a different shape from tablets intended for oral administration.
|
| 0‑L |
10913000
|
Effervescent vaginal tablet
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid single-dose preparation consisting of a vaginal tablet usually containing acid
substances and carbonates or hydrogen carbonates that react rapidly in the presence
of aqueous liquid to release carbon dioxide.
|
| 0‑L |
10914000
|
Medicated vaginal tampon
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid single-dose preparation consisting of a suitable material impregnated with active
substance(s) intended to be inserted in the vagina for a limited period of time.
|
| 0‑L |
10915000
|
Vaginal delivery system
|
0.4.0.127.0.16.1.1.2.1 |
|
Drug delivery system intended to be inserted in the vagina where it releases its contents
over an extended period of time. Medicated sponge and medicated vaginal tampon are
excluded.
|
| 0‑L |
11001000
|
Rectal cream
|
0.4.0.127.0.16.1.1.2.1 |
|
Semi-solid preparation consisting of a cream usually presented in a single-dose container
provided with a suitable applicator, intended for rectal use to obtain a local effect.
|
| 0‑L |
11002000
|
Rectal gel
|
0.4.0.127.0.16.1.1.2.1 |
|
Semi-solid preparation consisting of a gel usually presented in a single-dose container
provided with a suitable applicator, intended for rectal use to obtain a local effect.
|
| 0‑L |
11003000
|
Rectal ointment
|
0.4.0.127.0.16.1.1.2.1 |
|
Semi-solid preparation consisting of an ointment usually presented in a single-dose
container provided with a suitable applicator, intended for rectal use to obtain a
local effect.
|
| 0‑L |
11004000
|
Rectal foam
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation, usually presented in a pressurised container provided with an
applicator suitable for delivery to the rectum of foam containing large volumes of
gas dispersed in a liquid containing the active substance. Rectal foams are intended
for a local effect.
|
| 0‑L |
11005000
|
Rectal solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation consisting of a solution intended for rectal use or for diagnostic
purposes. Rectal solutions are usually presented in containers with a volume in the
range of 2.5 mL to 2000 mL. The container is fitted with an applicator or an applicator
is provided separately.
|
| 0‑L |
11006000
|
Rectal suspension
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation consisting of a suspension intended for rectal use or for diagnostic
purposes. Rectal suspension are usually presented in containers with a volume in the
range of 2.5 mL to 2000 mL. The container is fitted with an applicator or an applicator
is provided separately.
|
| 0‑L |
11007000
|
Rectal emulsion
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation consisting of an emulsion intended for rectal use or for diagnostic
purposes. Rectal emulsions are usually presented in containers with a volume in the
range of 2.5 mL to 2000 mL. The container is fitted with an applicator or an applicator
is provided separately.
|
| 0‑L |
11008000
|
Concentrate for rectal solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation intended to be diluted in the specified liquid to obtain a rectal
solution.
|
| 0‑L |
11009000
|
Powder for rectal solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of one or more powders, including freeze-dried powders,
intended to be dissolved in the specified liquid to obtain a rectal solution.
|
| 0‑L |
11010000
|
Powder for rectal suspension
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of one or more powders, including freeze-dried powders,
intended to be dispersed in the specified liquid to obtain a rectal suspension.
|
| 0‑L |
11011000
|
Tablet for rectal solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid, usually single-dose preparation consisting of a tablet, usually uncoated, intended
to be dissolved in the specified liquid to obtain a rectal solution.
|
| 0‑L |
11012000
|
Tablet for rectal suspension
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid, usually single-dose preparation consisting of a tablet, usually uncoated, intended
to be dispersed in the specified liquid to obtain a rectal suspension.
|
| 0‑L |
11013000
|
Suppository
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid single-dose preparation of a shape, size and consistency suitable for rectal
use, containing active substance(s) dispersed or dissolved in a suitable basis that
may be soluble or dispersible in water or may melt at body temperature.
|
| 0‑L |
11014000
|
Rectal capsule
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid single-dose preparation consisting of a soft capsule of elongated shape suitable
for rectal use, containing a liquid or semi-solid formulation, and which may have
a lubricating coating.
|
| 0‑L |
11015000
|
Rectal tampon
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid single-dose preparation consisting of a suitable material impregnated with active
substance(s) intended to be inserted in the rectum for a limited period of time usually
for a local effect.
|
| 0‑L |
11101000
|
Nebuliser solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation consisting of a solution intended for inhalation use. The solution
is converted into an aerosol by a continuously operating nebuliser or a metered-dose
nebuliser.
|
| 0‑L |
11102000
|
Nebuliser suspension
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation consisting of a suspension intended for inhalation use. The suspension
is converted into an aerosol by a continuously operating nebuliser or a metered-dose
nebuliser.
|
| 0‑L |
11103000
|
Powder for nebuliser suspension
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of one or more powders, including freeze-dried powders,
intended to be dispersed in the specified liquid to obtain a nebuliser suspension.
|
| 0‑L |
11104000
|
Powder for nebuliser solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of one or more powders, including freeze-dried powders,
intended to be dissolved in the specified liquid to obtain a nebuliser solution.
|
| 0‑L |
11105000
|
Nebuliser emulsion
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation consisting of an emulsion intended for inhalation to obtain local
effect or systemic delivery. The emulsion is converted into an aerosol by a continuously
operating nebuliser or a metered-dose nebuliser.
|
| 0‑L |
11106000
|
Pressurised inhalation, solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid, usually multidose preparation consisting of a solution intended for inhalation
use. The preparation is presented in a pressurised container usually fitted with a
metering dose valve.
|
| 0‑L |
11107000
|
Pressurised inhalation, suspension
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid, usually multidose preparation consisting of a suspension intended for inhalation
use. The preparation is presented in a pressurised container fitted with a metering
dose valve.
|
| 0‑L |
11108000
|
Pressurised inhalation, emulsion
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid, usually multidose preparation consisting of an emulsion intended for inhalation
use The preparation is presented in a pressurised container fitted with a metering
dose valve.
|
| 0‑L |
11109000
|
Inhalation powder
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid, usually multidose preparation intended for inhalation use, consisting of one
or more powders of solid active substance(s) to be administered by a dry-powder inhaler
containing a metering dose mechanism within the inhaler. 'Inhalation powder, hard
capsule' and 'Inhalation powder, pre-dispensed' are excluded.
|
| 0‑L |
11110000
|
Inhalation powder, hard capsule
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid single-dose preparation intended for inhalation use, consisting of one or more
powders of solid active substance(s) enclosed in a hard capsule. The capsule is loaded
into a dry-powder inhaler to generate an aerosol.
|
| 0‑L |
11111000
|
Inhalation powder, pre-dispensed
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation intended for inhalation use, consisting of one or more powders of
solid active substance(s) presented in a suitable pharmaceutical form other than a
hard capsule, either in the form of a single dose or divided into multiple single
doses. The preparation is loaded into a dry-powder inhaler to generate an aerosol.
|
| 0‑L |
11112000
|
Inhalation vapour, powder
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of one or more powders of solid active substance(s) intended
for generation of vapour to be inhaled to obtain a local effect. The vapour is usually
generated by adding the powder to hot water.
|
| 0‑L |
11113000
|
Inhalation vapour, capsule
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of a capsule formulation intended for generation of vapour
to be inhaled to obtain a local effect. The vapour is usually generated by adding
the whole capsule or the capsule contents to hot water.
|
| 0‑L |
11114000
|
Inhalation vapour, solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation consisting of a solution intended for generation of vapour to be
inhaled to obtain a local effect. The vapour is usually generated by adding the solution
to hot water.
|
| 0‑L |
11115000
|
Inhalation vapour, tablet
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of a tablet intended for generation of vapour to be inhaled
to obtain a local effect. The vapour is usually generated by adding the tablet to
hot water.
|
| 0‑L |
11116000
|
Inhalation vapour, ointment
|
0.4.0.127.0.16.1.1.2.1 |
|
Semi-solid preparation consisting of an ointment intended for generation of vapour
to be inhaled to obtain a local effect. The vapour may be generated by adding the
ointment to hot water.
|
| 0‑L |
11117000
|
Inhalation vapour, liquid
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation consisting of a liquid active substance per se, such as an essential
oil or a volatile anaesthetic, intended for generation of vapour to be inhaled. The
vapour may be generated by adding the liquid to hot water or by the use of a vaporising
device.
|
| 0‑L |
11201000
|
Solution for injection
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile single-dose or multidose preparation consisting of a solution intended
for administration by injection.
|
| 0‑L |
11202000
|
Suspension for injection
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile single-dose or multidose preparation consisting of a suspension intended
for administration by injection.
|
| 0‑L |
11203000
|
Emulsion for injection
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile single-dose or multidose preparation consisting of an emulsion intended
for administration by injection.
|
| 0‑L |
11204000
|
Gel for injection
|
0.4.0.127.0.16.1.1.2.1 |
|
Sterile single-dose preparation consisting of a hydrophilic gel intended for injection
into a specific tissue or organ.
|
| 0‑L |
11205000
|
Powder for solution for injection
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid sterile preparation consisting of one or more powders, including freeze-dried
powders, intended to be dissolved in the specified liquid to obtain a solution for
injection.
|
| 0‑L |
11206000
|
Powder for suspension for injection
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid sterile preparation consisting of one or more powders, including freeze-dried
powders, intended to be dispersed in the specified liquid to obtain a suspension for
injection.
|
| 0‑L |
11208400
|
Powder for prolonged-release suspension for injection
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid sterile preparation consisting of one or more powders, including freeze-dried
powders, intended to be dispersed in the specified liquid to obtain a prolonged-release
suspension for injection.
|
| 0‑L |
11208500
|
Prolonged-release suspension for injection
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile preparation consisting of a suspension intended for administration
by injection; the active substance(s) are released over an extended period of time.
|
| 0‑L |
11209000
|
Concentrate for solution for injection
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile preparation intended to be diluted in the specified liquid to obtain
a solution for injection.
|
| 0‑L |
11209500
|
Solution for cardioplegia
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile preparation consisting of an aqueous solution intended for use in inducing
cardiac arrest during heart surgery. Some preparations may require mixing with other
preparations prior to administration, for example to adjust the pH.
|
| 0‑L |
11210000
|
Solution for infusion
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile preparation consisting of an aqueous solution intended to be introduced,
usually in large volumes, usually into the circulating blood stream.
|
| 0‑L |
11211000
|
Emulsion for infusion
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile preparation consisting of an oil-in-water emulsion intended to be introduced,
usually in large volumes, usually into the circulating blood stream.
|
| 0‑L |
11211500
|
Powder for dispersion for infusion
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid sterile preparation consisting of one or more powders, including freeze-dried
powders, intended to be dispersed in the specified liquid to obtain a dispersion for
infusion.
|
| 0‑L |
11212000
|
Powder for solution for infusion
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid sterile preparation consisting of one or more powders, including freeze-dried
powders, intended to be dissolved in the specified aqueous liquid to obtain a solution
for infusion.
|
| 0‑L |
11213000
|
Concentrate for solution for infusion
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile preparation consisting of an aqueous solution intended to be diluted
in the specified aqueous liquid to obtain a solution for infusion. It may be added
to a solution for infusion during the administration.
|
| 0‑L |
11216000
|
Solvent for parenteral use
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile preparation consisting of a solvent containing no active substances,
intended for use in the preparation of a product for parenteral use.
|
| 0‑L |
11301000
|
Implant
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid sterile preparation of a size and shape suitable for implantation. It may be
prepared by moulding or other means other than compression. Each implant is presented
in a sterile container that may be provided with an administration device. Implants
are intended for release over an extended period of time in order to obtain local
or systemic effect.
'Implantation tablet', 'Implantation chain' and 'Implantation matrix' are excluded.
|
| 0‑L |
11302000
|
Implantation tablet
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid sterile preparation prepared by compression of a solid active substance as such
or of a formulation thereof into an implant of a size and shape suitable for implantation,
usually subcutaneously. Each implantation tablet is presented in a sterile container.
Implantation tablets are intended for release over an extended period of time in order
to obtain
local or systemic effect.
|
| 0‑L |
11303000
|
Implantation chain
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid sterile preparation consisting of small spheres mounted on a non-degradable
thread to form a chain that allows withdrawal of the remainder of the chain after
a certain period of action. Each implantation chain is presented in a sterile container.
The implantation chain is intended for release over an extended period of time in
order to obtain local or
systemic effect.
|
| 0‑L |
11303300
|
Implantation matrix
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid sterile preparation consisting of a usually pliable, absorbent piece of material
(e.g. collagen), usually impregnated with a liquid preparation, intended for implantation
in the body. The material may be cut into smaller pieces before implantation, and
may be shaped around a tissue (e.g. a bone) or inserted into a medical device that
is then implanted.
Implantation matrices are intended for release over an extended period of time, usually
in order to obtain a local effect. Usually the matrix disappears with time. When the
product is packaged as a separate matrix, powder and solvent (or matrix and solution),
which are used to prepare the implantation matrix immediately before use, the appropriate
combined term should be used;
see for example ‘Powder, solvent and matrix for implantation matrix’.
|
| 0‑L |
11303500
|
Implantation suspension
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile preparation consisting of a suspension intended for implantation in
the body; the active substance(s) are released over an extended period of time to
obtain a local or systemic effect.
|
| 0‑L |
11401000
|
Solution for peritoneal dialysis
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile preparation consisting of an aqueous solution containing electrolytes
with a concentration close to the electrolytic composition of plasma and glucose in
varying concentrations or other suitable osmotic agents, intended for intraperitoneal
use as a dialysis solution.
|
| 0‑L |
11402000
|
Solution for haemofiltration
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile preparation consisting of an aqueous solution containing electrolytes
with a concentration close to the electrolytic composition of plasma, intended for
parenteral use in haemofiltration. Glucose may be included.
|
| 0‑L |
11403000
|
Solution for haemodiafiltration
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile preparation consisting of an aqueous solution containing electrolytes
with a concentration close to the electrolytic composition of plasma, intended for
parenteral use in haemodiafiltration. Glucose may be included.
|
| 0‑L |
11404000
|
Solution for haemodialysis
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation consisting of an aqueous solution containing electrolytes with
a concentration close to the electrolytic composition of plasma, intended for use
in haemodialysis. Glucose may be included.
|
| 0‑L |
11405000
|
Concentrate for solution for haemodialysis
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation consisting of an aqueous solution of electrolytes intended to be
diluted with water of a suitable quality to obtain a solution for haemodialysis. Glucose
may be included.
|
| 0‑L |
11502000
|
Bladder irrigation
|
0.4.0.127.0.16.1.1.2.1 |
|
Sterile liquid preparation consisting of sterilised water or an aqueous solution intended
for irrigation of the urinary bladder.
|
| 0‑L |
11502500
|
Intravesical solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation consisting of an aqueous solution intended for intravesical use
by means of a suitable applicator. 'Bladder irrigation' is excluded.
|
| 0‑L |
11503000
|
Powder for bladder irrigation
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid sterile preparation consisting of one or more powders, including freeze-dried
powders, intended to be dissolved in sterile water to obtain a bladder irrigation.
|
| 0‑L |
11504000
|
Urethral gel
|
0.4.0.127.0.16.1.1.2.1 |
|
Semi-solid preparation consisting of a gel intended for urethral use by means of a
suitable applicator.
|
| 0‑L |
11505000
|
Urethral stick
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid sterile single-dose preparation, usually rod-shaped and of a size adapted to
the dimensions of the urethra, intended for insertion into the urethra. They may be
prepared by compression or moulding.
|
| 0‑L |
11601000
|
Endotracheopulmonary instillation, solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation consisting of an aqueous solution intended for instillation to
the trachea and/or bronchea. Preparations for inhalation use are excluded.
|
| 0‑L |
11602000
|
Endotracheopulmonary instillation, powder for solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of one or more powders, including freeze-dried powders,
intended to be dissolved in the specified liquid to obtain an endotracheopulmonary
instillation solution.
|
| 0‑L |
11603000
|
Endotracheopulmonary instillation, suspension
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation consisting of an aqueous suspension intended for instillation to
the trachea and/or bronchea. Preparations for inhalation use are excluded.
|
| 0‑L |
11701000
|
Endocervical gel
|
0.4.0.127.0.16.1.1.2.1 |
|
Semi-solid preparation consisting of a gel intended for endocervical use by means
of a suitable applicator.
|
| 0‑L |
11901000
|
Intrauterine delivery system
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid single-dose delivery system intended for intrauterine use that releases its
contents of active substance(s) over an extended period of time.
|
| 0‑L |
12101000
|
Denture lacquer
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation to be applied to dentures to form a lacquer by evaporation of the
volatile solvent.
|
| 0‑L |
12102000
|
Anticoagulant and preservative solution for blood
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile preparation consisting of an aqueous solution to be mixed with extracorporeal
blood.
|
| 0‑L |
12103000
|
Solution for blood fraction modification
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile preparation consisting of a solution intended for use in extracorporeal
modification of a blood fraction that is returned to the patient following modification.
|
| 0‑L |
12104000
|
Wound stick
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid sterile single-dose preparation, usually rod-shaped or conical, consisting of
active substance(s) dissolved or dispersed in a suitable basis that may dissolve or
melt at body temperature, intended to be inserted into wounds.
|
| 0‑L |
12105000
|
Radiopharmaceutical precursor
|
0.4.0.127.0.16.1.1.2.1 |
|
A radionuclide produced for the radio-labelling of another substance prior to administration.
|
| 0‑L |
12106000
|
Radionuclide generator
|
0.4.0.127.0.16.1.1.2.1 |
|
A system incorporating a fixed parent radionuclide from which is produced a daughter
radionuclide which is to be removed by elution or by any other method and used in
a radiopharmaceutical.
|
| 0‑L |
12107000
|
Kit for radiopharmaceutical preparation
|
0.4.0.127.0.16.1.1.2.1 |
|
A preparation to be reconstituted or combined with radionuclides in the final radiopharmaceutical,
usually prior to its administration. The word radiopharmaceutical may be omitted if
there is no ambiguity on the radiopharmaceutical nature of the product. Combinations
with other standard terms are not recommended.
|
| 0‑L |
12108000
|
Gastroenteral solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation consisting of a solution intended for administration to the stomach
or duodenum by means of a suitable applicator.
|
| 0‑L |
12110000
|
Gastroenteral suspension
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation consisting of a suspension intended for administration to the stomach
or duodenum by means of a suitable applicator.
|
| 0‑L |
12111000
|
Gastroenteral emulsion
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation consisting of an emulsion intended for administration to the stomach
or duodenum by means of a suitable applicator.
|
| 0‑L |
12111500
|
Intraperitoneal solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile preparation consisting of a solution intended for intraperitoneal use.
'Solution for peritoneal dialysis' is excluded.
|
| 0‑L |
12112000
|
Solution for organ preservation
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile preparation consisting of an aqueous solution of electrolytes typically
at a concentration close to the intracellular electrolyte composition, intended for
storage, protection and/or perfusion of mammalian body organs that are in particular
destined for transplantation.
|
| 0‑L |
12113000
|
Irrigation solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile preparation consisting of a large-volume aqueous solution intended
for irrigation of body cavities, wounds and surfaces, for example during surgical
procedures. Irrigation solutions are either solutions of active substance(s), electrolytes
or osmotically active substances in water for injections, or they consist of water
for injections as such.
|
| 0‑L |
12114000
|
Stomach irrigation
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile preparation consisting of an aqueous solution intended for irrigation
of the stomach.
|
| 0‑L |
12115000
|
Sealant
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid, more or less viscous, sterile preparation intended for use as tissue glue.
|
| 0‑L |
12115100
|
Sealant matrix
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid sterile preparation consisting of a pliable piece of material impregnated or
coated with a sealant or with a powder that forms a sealant after contact with an
appropriate fluid (e.g. blood). It may act as a haemostatic agent and/or tissue glue.
The matrix may itself form part of the seal, and is usually absorbed by the body over
time.
|
| 0‑L |
12115200
|
Sealant powder
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid sterile preparation consisting of one or more powders, including freeze-dried
powders, intended to be applied directly onto the intended site (e.g. a lesion) to
form a haemostatic agent and/or tissue glue after contact with an appropriate fluid
(e.g. blood).
|
| 0‑L |
12117000
|
Impregnated pad
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of a piece of absorbent material impregnated with a liquid
preparation.
|
| 0‑L |
12117500
|
Impregnated plug
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of a piece of material (e.g. polyethylene), usually porous,
in which a liquid, semi-solid or solid preparation is impregnated. Implants, pads,
sponges and tampons are excluded.
|
| 0‑L |
12118000
|
Living tissue equivalent
|
0.4.0.127.0.16.1.1.2.1 |
|
Cultured, living tissue used for the reconstruction of parts of the body. The tissue
may consist of ex vivo expanded cells with an extracellular matrix. Where appropriate,
the tissue of origin, such as epidermis, dermis, cartilage or muscle, will need to
be stated elsewhere in the product information.
|
| 0‑L |
12119000
|
Medicated sponge
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of a sponge impregnated with active substance(s); different
routes of administration are possible.
|
| 0‑L |
12120000
|
Intestinal gel
|
0.4.0.127.0.16.1.1.2.1 |
|
Semi-solid preparation consisting of a gel intended for intestinal use. |
| 0‑L |
12130000
|
Medicated thread
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of a biodegradable or non-degradable thread impregnated
with active substance(s).
|
| 0‑L |
12131000
|
Solution for provocation test
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation consisting of a solution containing an allergen intended for provocation
testing by the nasal, ocular or bronchial routes.
|
| 0‑L |
12301000
|
Medicinal gas, compressed
|
0.4.0.127.0.16.1.1.2.1 |
|
A gas packaged under pressure which is entirely gaseous at - 50 °C. |
| 0‑L |
12302000
|
Medicinal gas, cryogenic
|
0.4.0.127.0.16.1.1.2.1 |
|
a gas which liquifies at 1.013 bar at a temperature below -150 °C. |
| 0‑L |
12303000
|
Medicinal gas, liquefied
|
0.4.0.127.0.16.1.1.2.1 |
|
A gas packaged under pressure, which is partially liquid (gas over liquid) at -50
°C.
|
| 0‑L |
13001000
|
Concentrate for concentrate for solution for infusion
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile preparation intended to be diluted in the specified liquid to obtain
a concentrate for solution for infusion, which in turn is intended to be diluted in
the specified liquid to obtain a solution for infusion.
|
| 0‑L |
13002000
|
Concentrate for nebuliser solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation intended to be diluted in the specified liquid to obtain a nebuliser
solution.
|
| 0‑L |
13003000
|
Concentrate for oromucosal solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation intended to be diluted in the specified liquid to obtain an oromucosal
solution.
|
| 0‑L |
13004000
|
Concentrate for suspension for injection
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile preparation intended to be diluted in the specified liquid to obtain
a suspension for injection.
|
| 0‑L |
13005000
|
Dispersion for concentrate for dispersion for infusion
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile preparation consisting of a dispersion intended for use in the preparation
of a concentrate for dispersion for infusion, which in turn is intended to be diluted
in the specified liquid to obtain a dispersion for infusion.
|
| 0‑L |
13006000
|
Ear drops, powder for suspension
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of one or more powders, including freeze-dried powders,
intended to be dispersed in the specified liquid to obtain an ear drops suspension.
|
| 0‑L |
13007000
|
Effervescent granules for oral suspension
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of effervescent granules intended to be dispersed or
dissolved in the specified liquid, which is supplied in the same packaging, to obtain
an oral suspension. Where the granules are intended to be dispersed in water, the
term 'Effervescent granules' is used instead.
|
| 0‑L |
13008000
|
Emulsion for emulsion for injection
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile preparation consisting of an emulsion intended for use in the preparation
of an emulsion for injection.
|
| 0‑L |
13009000
|
Endotracheopulmonary instillation, powder for suspension
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of one or more powders, including freeze-dried powders,
intended to be dispersed in the specified liquid to obtain an endotracheopulmonary
instillation suspension.
|
| 0‑L |
13010000
|
Eye drops, powder for solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid sterile preparation consisting of one or more powders, including freeze-dried
powders, intended to be dissolved in the specified liquid to obtain an eye drops solution.
|
| 0‑L |
13011000
|
Eye drops, powder for suspension
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of one or more powders, including freeze-dried powders,
intended to be dispersed in the specified liquid to obtain an eye drops suspension.
|
| 0‑L |
13012000
|
Gas for dispersion for infusion
|
0.4.0.127.0.16.1.1.2.1 |
|
Sterile preparation consisting of a gas that is intended to be mixed with the specified
liquid to obtain a dispersion of the gas in the liquid, which is intended for administration
by infusion.
|
| 0‑L |
13013000
|
Gas for dispersion for injection
|
0.4.0.127.0.16.1.1.2.1 |
|
Sterile preparation consisting of a gas that is intended to be mixed with the specified
liquid to obtain a dispersion of the gas in the liquid, which is intended for administration
by injection.
|
| 0‑L |
13014000
|
Gel for gel
|
0.4.0.127.0.16.1.1.2.1 |
|
Semi-solid preparation consisting of a gel intended for use in the preparation of
a gel for cutaneous use.
|
| 0‑L |
13015000
|
Granules for rectal suspension
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of aggregated particles that may include excipients to
facilitate wetting and dispersion, intended to be dispersed in the specified liquid
to obtain a rectal suspension, which is usually prepared just before administration
to the patient.
|
| 0‑L |
13016000
|
Laryngopharyngeal solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation consisting of a solution intended for administration to the laryngopharynx
for a local effect, other than by spraying.
|
| 0‑L |
13017000
|
Laryngopharyngeal spray, solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation consisting of a solution intended for spraying onto the laryngopharynx
for a local effect.
|
| 0‑L |
13018000
|
Matrix for implantation matrix
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid sterile preparation consisting of a usually pliable, absorbent piece of material
(e.g. collagen) intended to be used in the preparation of an implantation matrix.
|
| 0‑L |
13020000
|
Nasal drops, powder for solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of one or more powders, including freeze-dried powders,
intended to be dissolved in the specified liquid to obtain a nasal drops solution.
|
| 0‑L |
13021000
|
Powder for gel
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of one or more powders intended to be mixed with the
specified liquid or gel to obtain a gel (for cutaneous use).
|
| 0‑L |
13022000
|
Powder for dental gel
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of one or more powders intended to be mixed with the
specified liquid or gel to obtain a dental gel.
|
| 0‑L |
13023000
|
Powder for dispersion for injection
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid sterile preparation consisting of one or more powders, including freeze-dried
powders, intended to be dispersed in the specified liquid to obtain a dispersion for
injection.
|
| 0‑L |
13024000
|
Powder for endocervical gel
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of one or more powders intended to be mixed with the
specified liquid or gel to obtain an endocervical gel.
|
| 0‑L |
13025000
|
Powder for endosinusial solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of one or more powders, including freeze-dried powders,
intended to be dissolved in the specified liquid to obtain an endosinusial solution.
|
| 0‑L |
13026000
|
Powder for gingival gel
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of one or more powders intended to be mixed with the
specified liquid or gel to obtain a gingival gel.
|
| 0‑L |
13027000
|
Powder for implantation matrix
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid sterile preparation consisting of one or more powders, including freeze-dried
powders, intended to be used in the preparation of an implantation matrix, e.g. by
dissolving in the specified liquid to prepare the solution used to impregnate the
matrix.
|
| 0‑L |
13028000
|
Powder for implantation paste
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid sterile preparation consisting of one or more powders intended to be mixed with
the specified liquid or paste to obtain an implantation paste.
|
| 0‑L |
13029000
|
Powder for intraocular instillation solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid sterile preparation consisting of one or more powders, including freeze-dried
powders, intended to be dissolved in the specified liquid to obtain an intraocular
instillation solution.
|
| 0‑L |
13031000
|
Powder for sealant
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid sterile preparation consisting of one or more powders, including freeze-dried
powders, intended to be dissolved in the specified liquid to obtain a sealant.
|
| 0‑L |
13032000
|
Powder for solution for skin-prick test
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid sterile preparation consisting of one or more powders, including freeze-dried
powders, intended to be dissolved in the specified liquid to obtain a solution for
skin-prick test.
|
| 0‑L |
13033000
|
Solution for solution for injection
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile preparation consisting of a solution intended for use in the preparation
of a solution for injection.
|
| 0‑L |
13035000
|
Solvent for...
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation consisting of an excipient that contains no active substances itself
but is intended to be used in the preparation of a pharmaceutical product, e.g. for
diluting/dissolving/dispersing the item(s) containing the active substance(s). The
term is intended to cover all such excipients, with the particular specifications
(e.g. sterility
requirements) depending on the final product and its intended use.
|
| 0‑L |
13036000
|
Suspension for emulsion for injection
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile preparation consisting of a suspension intended for use in the preparation
of an emulsion for injection.
|
| 0‑L |
13037000
|
Suspension for oral suspension
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation consisting of a suspension intended for use in the preparation
of an oral suspension.
|
| 0‑L |
13039000
|
Suspension for suspension for injection
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile preparation consisting of a suspension intended for use in the preparation
of a suspension for injection.
|
| 0‑L |
13040000
|
Powder for emulsion for injection
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid sterile preparation consisting of one or more powders, including freeze-dried
powders, intended to be mixed with the specified liquid to obtain an emulsion for
injection.
|
| 0‑L |
13041000
|
Endosinusial solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation consisting of a solution intended to be administered to the sinuses
to obtain a local effect.
|
| 0‑L |
13042000
|
Epilesional solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile preparation consisting of a solution intended to be administered onto
a lesion.
|
| 0‑L |
13043000
|
Implantation paste
|
0.4.0.127.0.16.1.1.2.1 |
|
Semi-solid sterile preparation containing large proportions of solids finely dispersed
in the basis, intended to be implanted in the body for release of the active substance(s)
over an extended period of time, usually to obtain a systemic effect.
|
| 0‑L |
13044000
|
Intraocular instillation solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile preparation consisting of a solution intended to be instilled as drops
into an internal part of the eye.
|
| 0‑L |
13045000
|
Intravesical suspension
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation consisting of a small-volume suspension intended for intravesical
use by means of a suitable applicator.
|
| 0‑L |
13046000
|
Coated granules
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation intended for oral use, consisting of granules coated with one or
more layers of mixtures of various substances that are usually applied as a solution
or suspension in conditions in which evaporation of the vehicle occurs. When the coating
dissolves or disintegrates any active substance is released into the gastrointestinal
fluid at a rate
depending essentially on its intrinsic properties (conventional release).
|
| 0‑L |
13047000
|
Solution for suspension for injection
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile preparation consisting of a solution intended for use in the preparation
of a suspension for injection.
|
| 0‑L |
13048000
|
Granules for suspension for injection
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid sterile preparation consisting of granules intended to be dispersed in the specified
liquid to obtain a suspension for injection.
|
| 0‑L |
13049000
|
Dispersion for injection/infusion
|
0.4.0.127.0.16.1.1.2.1 |
|
Sterile liquid preparation consisting of two or more phases of which at least one
is dispersed in the liquid phase, intended for administration by injection or infusion.
To be used only when emulsion for injection/infusion is not appropriate. Solid suspension
preparations are excluded.
|
| 0‑L |
13050000
|
Gas for dispersion for injection/infusion
|
0.4.0.127.0.16.1.1.2.1 |
|
Sterile preparation consisting of a gas that is intended to be mixed with the specified
liquid to obtain a dispersion of the gas in the liquid, which is intended for administration
by injection or infusion.
|
| 0‑L |
13051000
|
Solution for injection/skin-prick test
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile preparation consisting of a solution containing an allergen product
intended for diagnostic use in a skin-prick test or as an injection (usually intraepidermal);
it may also be licensed for immunotherapy treatment by injection (usually subcutaneous).
|
| 0‑L |
13052000
|
Powder for solution for injection/skin-prick test
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid sterile preparation consisting of one or more powders, including freeze-dried
powders, intended to be dissolved in the specified liquid to obtain a solution for
injection/skin-prick test.
|
| 0‑L |
13061000
|
Solution for solution for infusion
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile preparation consisting of a solution intended for use in the preparation
of a solution for infusion.
|
| 0‑L |
13066000
|
Tablet for cutaneous solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid, usually single-dose preparation consisting of a tablet, usually uncoated, intended
to be dissolved in the specified liquid to obtain a cutaneous solution.
|
| 0‑L |
13076000
|
Prolonged-release solution for injection
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile preparation consisting of a solution intended for administration by
injection; the active substance(s) are released over an extended period of time.
|
| 0‑L |
13077000
|
Urethral emulsion
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation consisting of an emulsion intended for urethral use by means of
a suitable applicator.
|
| 0‑L |
13091000
|
Emulsion for suspension for injection
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile preparation consisting of an emulsion intended for use in the preparation
of a suspension for injection.
|
| 0‑L |
13102000
|
Transdermal ointment
|
0.4.0.127.0.16.1.1.2.1 |
|
Semi-solid single-dose or multidose preparation consisting of a single-phase basis
in which solids or liquids may be dispersed. Active substance(s) are dissolved or
dispersed in the basis, which may be hydrophilic, hydrophobic or water-emulsifying.
Transdermal ointments are intended for transdermal use.
|
| 0‑L |
13105000
|
Sublingual powder
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of a powder intended for sublingual use. |
| 0‑L |
13106000
|
Oral herbal material
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of whole, broken or fragmented plants or parts of plants
in an unprocessed state (herbal drug), intended for oral use without requiring transformation
(e.g. dissolution or dispersion in water); the material may be dried or fresh, and
may be chewed before being swallowed. The word ‘plant’ is used in the broader sense
to include
also algae, fungi and lichens. Certain exudates that have not been subjected to a
specific treatment may be included. Herbal teas and instant herbal teas are excluded,
as are preparations that are processed or formulated into capsules, granules, powders,
etc.
|
| 0‑L |
13107000
|
Solution for cardioplegia/organ preservation
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile preparation consisting of an aqueous solution of electrolytes typically
at a concentration close to the intracellular electrolyte composition, intended for
inducing cardiac arrest during heart surgery, and for storage, protection and/or perfusion
of mammalian body organs that are in particular destined for transplantation.
|
| 0‑L |
30047500
|
Pouch
|
0.4.0.127.0.16.1.1.2.1 |
|
Small bag made of a suitable material containing a single dose of a medicinal product,
to be placed in a cavity of the body for release of the active substance(s)
|
| 0‑L |
50001000
|
Chewable/dispersible tablet
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid single-dose preparation consisting of an uncoated tablet intended either to
be chewed before being swallowed, or to be dispersed in the specified liquid before
being swallowed.
|
| 0‑L |
50009000
|
Concentrate for cutaneous spray, emulsion
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation intended to be diluted in the specified liquid to obtain a cutaneous
spray emulsion.
|
| 0‑L |
50009300
|
Concentrate for dispersion for infusion
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile preparation intended to be diluted in the specified liquid to obtain
a dispersion for infusion.
|
| 0‑L |
50009500
|
Concentrate for emulsion for infusion
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile preparation intended to be diluted in the specified liquid to obtain
an emulsion for infusion.
|
| 0‑L |
50009750
|
Concentrate for intravesical solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation intended to be diluted in the specified liquid to obtain an intravesical
solution.
|
| 0‑L |
50010000
|
Concentrate for oral solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation intended to be diluted in the specified liquid to obtain an oral
solution.
|
| 0‑L |
50011000
|
Concentrate for oral/rectal solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation intended to be diluted in the specified liquid to obtain an oral/rectal
solution.
|
| 0‑L |
50013250
|
Concentrate for solution for peritoneal dialysis
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile preparation intended to be diluted in the specified liquid to obtain
a solution for peritoneal dialysis.
|
| 0‑L |
50015200
|
Cutaneous/nasal ointment
|
0.4.0.127.0.16.1.1.2.1 |
|
Semi-solid preparation consisting of an ointment intended for cutaneous or nasal use.
|
| 0‑L |
50015450
|
Cutaneous solution/concentrate for oromucosal solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation consisting of a solution intended for cutaneous use or intended
to be diluted in the specified liquid to obtain an oromucosal solution.
|
| 0‑L |
50015500
|
Cutaneous spray, emulsion
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation, usually multidose, consisting of an emulsion in a pressurised
container with a spray valve or in a container equipped with a spray pump, intended
for cutaneous use.
|
| 0‑L |
50016000
|
Cutaneous spray, ointment
|
0.4.0.127.0.16.1.1.2.1 |
|
Ointment formed at the time of administration from a liquid preparation in a pressurised
container with a spray valve or in a container equipped with a spray pump.
|
| 0‑L |
50017000
|
Dental paste
|
0.4.0.127.0.16.1.1.2.1 |
|
Semi-solid single-dose or multidose preparation consisting of solid particles finely
dispersed in a suitable basis, intended for administration on or inside the tooth
or on and/or around the nerves supplying the teeth. Toothpaste is excluded.
|
| 0‑L |
50017500
|
Dispersion for infusion
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile preparation consisting of two or more phases of which at least one
is dispersed in the liquid phase, intended to be introduced, usually in large volumes,
usually into the circulating blood stream. To be used only when emulsion for infusion
is not appropriate. Solid suspension preparations are excluded.
|
| 0‑L |
50018000
|
Ear/eye drops, solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile preparation consisting of a solution intended for use as ear drops
or eye drops.
|
| 0‑L |
50018500
|
Ear/eye drops, suspension
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile preparation consisting of a suspension intended for use as ear drops
or eye drops.
|
| 0‑L |
50019000
|
Ear/eye ointment
|
0.4.0.127.0.16.1.1.2.1 |
|
Semi-solid preparation consisting of an ointment intended for auricular or ocular
use.
|
| 0‑L |
50019500
|
Ear/eye/nasal drops, solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile preparation consisting of a solution intended for use as ear drops,
eye drops or nasal drops.
|
| 0‑L |
50020200
|
Ear/nasal drops, suspension
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation consisting of a suspension intended for use as ear drops or nasal
drops.
|
| 0‑L |
50021000
|
Emulsion for injection/infusion
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile single-dose or multidose preparation consisting of an emulsion intended
for administration by injection or infusion.
|
| 0‑L |
50022000
|
Endosinusial wash, suspension
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation consisting of a suspension intended for cleaning the sinuses. |
| 0‑L |
50024000
|
Gargle/mouthwash
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation consisting of a solution intended for use as a gargle or a mouthwash.
|
| 0‑L |
50024500
|
Gargle/nasal wash
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation consisting of a solution intended for use as a gargle or a nasal
wash.
|
| 0‑L |
50026000
|
Gastro-resistant granules for oral suspension
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of gastro-resistant granules intended to be dispersed
in the specified liquid to obtain an oral suspension.
|
| 0‑L |
50029150
|
Granules for oral/rectal suspension
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of granules intended to be dispersed in the specified
liquid to obtain an oral/rectal suspension.
|
| 0‑L |
50029500
|
Granules for vaginal solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of aggregated particles that may include excipients to
facilitate wetting and dissolution, intended to be dissolved in the specified liquid
to obtain a vaginal solution, which is usually prepared just before administration
to the patient.
|
| 0‑L |
50030000
|
Inhalation powder, tablet
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid multidose preparation intended for inhalation use. The dose of inhalation powder
is generated from the tablet by a metering mechanism within the inhaler, for example
by scraping off a small amount of powder from the tablet.
|
| 0‑L |
50031000
|
Inhalation vapour, effervescent tablet
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of a tablet usually containing acid substances and carbonates
or hydrogen carbonates that react rapidly in the presence of aqueous liquid to release
carbon dioxide, intended for generation of vapour to be inhaled to obtain a local
effect. The vapour may be generated by adding the tablet to hot water.
|
| 0‑L |
50032000
|
Inhalation vapour, emulsion
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation consisting of an emulsion intended for generation of vapour to
be inhaled to obtain a local effect. The vapour may be generated by adding the emulsion
to hot water.
|
| 0‑L |
50033000
|
Inhalation vapour, impregnated pad
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of a piece of absorbent material impregnated usually
with a liquid or semi-solid preparation, intended for generation of vapour to be inhaled
to obtain a local effect.
|
| 0‑L |
50033100
|
Inhalation vapour, impregnated plug
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of an impregnated plug that generates a vapour to be
inhaled, for example by the patient inhaling through a device containing the plug,
thereby drawing air through or over it and vaporising the active ingredient(s) impregnated
therein.
|
| 0‑L |
50033400
|
Intravesical solution/solution for injection
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile preparation consisting of a solution intended for intravesical use
or for administration by injection.
|
| 0‑L |
50036000
|
Modified-release granules for oral suspension
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of modified-release granules intended to be dispersed
in the specified liquid to obtain an oral suspension.
|
| 0‑L |
50036050
|
Mouthwash, powder for solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of one or more powders, including freeze-dried powders,
intended to be dissolved in the specified liquid to obtain a mouthwash.
|
| 0‑L |
50036500
|
Nasal/oromucosal solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation consisting of a solution intended for nasal or oromucosal application.
'Nasal/oromucosal spray, solution' and 'Nasal spray, solution/oromucosal solution'
are excluded.
|
| 0‑L |
50036700
|
Nasal/oromucosal spray, solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation consisting of a solution in a container with or without a metering
dose valve or in a container with a spray pump, intended for nasal or oromucosal use.
|
| 0‑L |
50037100
|
Nasal spray, powder for solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of one or more powders, including freeze-dried powders,
intended to be dissolved in the specified liquid to obtain a nasal spray solution.
|
| 0‑L |
50037400
|
Nasal spray, solution/oromucosal solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation consisting of a solution intended for use as a nasal spray or an
oromucosal solution.
|
| 0‑L |
50037500
|
Oral drops, granules for solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of granules intended to be dissolved in the specified
liquid to obtain an oral drops solution.
|
| 0‑L |
50037750
|
Oral drops, liquid
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid, usually multidose preparation consisting of a liquid active substance per
se, intended for oral use. The preparation is administered in small volumes by means
of a suitable measuring device such as a dropper, pipette or oral syringe capable
of accurate dosing of the liquid. The measured dose may be diluted in water or another
suitable liquid before
swallowing.
|
| 0‑L |
50037900
|
Oral/rectal solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation consisting of a solution intended for oral or rectal use. |
| 0‑L |
50038000
|
Oral/rectal suspension
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation consisting of a suspension intended for oral or rectal use. |
| 0‑L |
50038500
|
Oral solution/concentrate for nebuliser solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation consisting of a solution intended for oral use or intended to be
diluted in the specified liquid to obtain a nebuliser solution.
|
| 0‑L |
50039000
|
Oromucosal patch
|
0.4.0.127.0.16.1.1.2.1 |
|
Flexible single-dose preparation intended to be applied to the oral cavity to obtain
either a systemic or a local effect by delivering the active substance(s) over a certain
period of time, after which it is then removed.
|
| 0‑L |
50039500
|
Oromucosal/laryngopharyngeal solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation consisting of a solution intended for oromucosal or laryngopharyngeal
use. 'Oromucosal/laryngopharyngeal solution/spray, solution' is excluded.
|
| 0‑L |
50040500
|
Oromucosal/laryngopharyngeal solution/spray, solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation consisting of a solution intended for oromucosal or laryngopharyngeal
use, presented in a container with an optional spray device to allow administration
as a spray.
|
| 0‑L |
50043000
|
Powder for concentrate for solution for infusion
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid sterile preparation consisting of one or more powders, including freeze-dried
powders, intended to be dissolved in the specified liquid to obtain a concentrate
for solution for infusion, which must subsequently be diluted before administration
as a solution for infusion.
|
| 0‑L |
50048750
|
Powder for concentrate for dispersion for infusion
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid sterile preparation consisting of one or more powders, including freeze-dried
powders, intended to be dispersed in the specified liquid to obtain a concentrate
for dispersion for infusion, which must subsequently be diluted before administration
as a dispersion for infusion.
|
| 0‑L |
50049100
|
Powder for concentrate for intravesical suspension
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid sterile preparation consisting of one or more powders, including freeze-dried
powders, intended to be dispersed in the specified liquid to obtain a concentrate
for intravesical suspension, which must subsequently be diluted before administration
as an intravesical suspension.
|
| 0‑L |
50049200
|
Powder for concentrate for solution for haemodialysis
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid sterile preparation consisting of one or more powders, including freeze-dried
powders, intended to be dissolved in the specified liquid to obtain a concentrate
for solution for haemodialysis, which must subsequently be diluted before use as a
solution for haemodialysis.
|
| 0‑L |
50049250
|
Powder for concentrate for solution for injection/infusion
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid sterile preparation consisting of one or more powders, including freeze-dried
powders, intended to be dissolved in the specified liquid to obtain a concentrate
for solution for injection/infusion, which must subsequently be diluted before administration
as a solution for injection/infusion.
|
| 0‑L |
50049270
|
Powder for dental solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of one or more powders, including freeze-dried powders,
intended to be dissolved in the specified liquid to obtain a dental solution.
|
| 0‑L |
50049300
|
Powder for epilesional solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid sterile preparation consisting of one or more powders, including freeze-dried
powders, intended to be dissolved in the specified liquid to obtain an epilesional
solution.
|
| 0‑L |
50049500
|
Powder for implantation suspension
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid sterile preparation consisting of one or more powders, including freeze-dried
powders, intended to be dispersed in the specified liquid to obtain an implantation
suspension.
|
| 0‑L |
50050000
|
Powder for intravesical solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of one or more powders, including freeze-dried powders,
intended to be dissolved in the specified liquid to obtain an intravesical solution.
|
| 0‑L |
50050500
|
Powder for intravesical solution/solution for injection
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid sterile preparation consisting of one or more powders, including freeze-dried
powders, intended to be dissolved in the specified liquid to obtain an intravesical
solution/solution for injection.
|
| 0‑L |
50051000
|
Powder for intravesical suspension
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of one or more powders, including freeze-dried powders,
intended to be dispersed in the specified liquid to obtain an intravesical suspension.
|
| 0‑L |
50052000
|
Powder for oral/rectal suspension
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of one or more powders, including freeze-dried powders,
intended to be dissolved in the specified liquid to obtain an oral/rectal solution.
|
| 0‑L |
50053500
|
Powder for solution for injection/infusion
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid sterile preparation consisting of one or more powders, including freeze-dried
powders, intended to be dissolved in the specified liquid to obtain a solution for
injection/infusion.
|
| 0‑L |
50056000
|
Prolonged-release granules for oral suspension
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of prolonged-release granules intended to be dispersed
in the specified liquid to obtain an oral suspension.
|
| 0‑L |
50056500
|
Radiopharmaceutical precursor, solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid preparation consisting of a solution containing a radionuclide produced for
the radio-labelling of another substance prior to administration.
|
| 0‑L |
50057000
|
Solution for haemodialysis/haemofiltration
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile preparation consisting of a solution intended for use as a solution
for haemodialysis or a solution for haemofiltration.
|
| 0‑L |
50060000
|
Solution for injection/infusion
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile single-dose or multidose preparation consisting of a solution intended
for administration by injection or infusion.
|
| 0‑L |
50061500
|
Solution for sealant
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile preparation consisting of a solution intended for the preparation of
a sealant.
|
| 0‑L |
50073000
|
Powder for solution for intraocular irrigation
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid sterile preparation consisting of one or more powders, including freeze-dried
powders, intended to be dissolved in the specified liquid to obtain a solution for
intraocular irrigation.
|
| 0‑L |
50073500
|
Solution for intraocular irrigation
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile preparation consisting of a solution intended for irrigation of one
or more internal structures of the eye, for example during surgical procedures.
|
| 0‑L |
50074000
|
Solvent for solution for intraocular irrigation
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile preparation consisting of a solvent containing no active substances,
intended for use in the preparation of a solution for intraocular irrigation.
|
| 0‑L |
50076000
|
Solvent for solution for infusion
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile preparation consisting of a solvent containing no active substances,
intended for use in the preparation of a solution for infusion.
|
| 0‑L |
50077000
|
Dispersion for injection
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile preparation consisting of two or more phases of which at least one
is dispersed in the liquid phase, intended for administration by injection. To be
used only when emulsion for injection is not appropriate. Solid suspension preparations
are excluded.
|
| 0‑L |
50079000
|
Concentrate for solution for injection/infusion
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid sterile preparation intended to be diluted in the specified liquid to obtain
a solution for injection/infusion.
|
| 0‑L |
50081000
|
Inhalation solution
|
0.4.0.127.0.16.1.1.2.1 |
|
Liquid, usually multidose preparation consisting of a solution intended for inhalation
use. The preparation is presented in a non-pressurised container fitted with a metering
dose mechanism. 'Nebuliser solution' and 'Pressurised inhalation, solution' are excluded.
|
| 0‑L |
50082000
|
Oral drops, powder for suspension
|
0.4.0.127.0.16.1.1.2.1 |
|
Solid preparation consisting of one or more powders, including freeze-dried powders,
intended to be dispersed in the specified liquid to obtain an oral drops suspension.
|
|
Value Set Pharmaceutical Dose Form (EDQM) 2018‑04‑10 16:57:30
Under pre-publication review
