Age-appropriate dosage form, other

Age-appropriate oral liquid dosage form

Age-appropriate oral solid dosage form

Age-appropriate dosage form for parenteral use

Age-appropriate dosage form for rectal use

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.

Liquid sterile preparation consisting of a solvent containing no active substances, intended for use in the preparation of a solution for infusion.

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.

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.

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.

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.

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).

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.

Liquid preparation consisting of a dispersion intended for inhalation use. The dispersion is converted into an aerosol by a continuously operating nebuliser or a metered-dose nebuliser.

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.

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.

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.

Solid single-dose preparation, rod-shaped and usually prepared by compression or moulding, intended for dental use.

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.

Semi-solid single-dose or multidose preparation consisting of a cream, usually of oil-in-water type, intended for nasal use, usually to obtain a local effect. Nasal creams are usually presented in tubes fitted with a nasal applicator.

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

Liquid sterile preparation consisting of a solution containing an allergen product intended for diagnostic use in a skin-prick test.

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.

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.

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.

Liquid sterile preparation consisting of a solvent containing no active substances, intended for use in the preparation of a solution for intraocular irrigation.

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.

Solid preparation consisting of prolonged-release granules intended to be dispersed in the specified liquid to obtain a prolonged-release oral suspension.

Liquid preparation consisting of a solution containing a radionuclide produced for the radio-labelling of another substance prior to administration.

Solid preparation consisting of a gastro-resistant powder intended to be dispersed in the specified liquid to obtain a gastro-resistant oral suspension.

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.

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.

Liquid sterile preparation consisting of a solution intended for use as ear drops or eye drops.

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.

Liquid sterile preparation consisting of a solution intended for use in the preparation of a solution for infusion.

Liquid single-dose or multidose preparation consisting of a solution intended for nasal use by means of a suitable applicator.

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.

Liquid single-dose or multidose preparation consisting of usually an aqueous isotonic solution intended for cleansing the nasal cavities.

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.

Liquid single-dose or multidose preparation consisting of a solution intended for oromucosal use.

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.

Semi-solid preparation consisting of a gel intended to be placed in the pouch between the tooth and the gingiva.

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.

Liquid sterile preparation consisting of a suspension intended for use as ear drops or eye drops.

Liquid sterile preparation consisting of a solution intended for use in the preparation of a solution for injection.

Liquid preparation consisting of an aqueous solution intended for instillation to the trachea and/or bronchi. Preparations for inhalation use are excluded.

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.

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.

Liquid preparation consisting of a solution intended for oral use or intended to be diluted in the specified liquid to obtain a nebuliser solution.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Solid single-dose preparation consisting of a tablet, usually uncoated, intended to be dissolved in the specified liquid before being swallowed.

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.

Liquid, usually multidose preparation consisting of a solution intended for sublingual use. Sublingual sprays are usually presented in pressurised containers with a metering valve.

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.

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.

A gas which liquifies at 1.013 bar at a temperature below -150 °C.

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.

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.

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.

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.

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.

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.

Solid single-dose preparation of usually conical shape intended to be inserted in the external auditory meatus where it melts or dissolves.

Semi-solid single-dose or multidose preparation consisting of usually a hydrophilic gel, intended for nasal use, usually to obtain a local effect. Nasal gels are usually presented in tubes fitted with a nasal applicator.

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.

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.

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.

Solid sterile preparation consisting of granules intended to be dispersed in the specified liquid to obtain a suspension for injection.

Solid single-dose delivery system intended for intrauterine use that releases its contents of active substance(s) over an extended period of time.

Liquid sterile preparation consisting of a solvent containing no active substances, intended for use in the preparation of a product for parenteral use.

Liquid, usually multidose preparation consisting of a suspension intended for sublingual use. Sublingual sprays are usually presented in pressurised containers with a metering valve.

Liquid sterile preparation consisting of a solution intended for administration by injection; the active substance(s) are released over an extended period of time.

Solid preparation consisting of a powder intended for sublingual use.

Liquid sterile preparation consisting of a suspension intended for use in the preparation of a suspension for injection.

Liquid sterile preparation consisting of a solution intended to be administered onto a lesion.

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.

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.

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.

Liquid preparation consisting of a solution intended to be administered to the sinuses to obtain a local effect.

Liquid preparation consisting of a suspension intended for use as ear drops or nasal drops.

Solid preparation consisting of gastro-resistant granules intended to be dispersed in the specified liquid to obtain a gastro-resistant oral suspension.

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.

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.

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.

Pharmaceutical dose form not applicable

Liquid sterile preparation consisting of a solution intended for use in the preparation of a suspension for injection.

Liquid sterile single-dose or multidose preparation consisting of an emulsion intended for administration by injection.

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.

Liquid sterile preparation consisting of a solution intended for use as a solution for haemodialysis or a solution for haemofiltration.

Semi-solid preparation consisting of a gel intended for use in the preparation of a gel for cutaneous use.

A gas packaged under pressure which is entirely gaseous at - 50 °C.

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.

Solid preparation consisting of one or more powders intended to be mixed with the specified liquid or gel to obtain a dental gel.

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.

Liquid single-dose or multidose preparation consisting of an emulsion intended for nasal use by means of a suitable applicator.

Semi-solid single-dose or multidose preparation consisting of an ointment, intended for nasal use, usually to obtain a local effect. Nasal ointments are usually presented in tubes fitted with a nasal applicator.

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.

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.

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.

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.

Semi-solid preparation consisting of an ointment intended for auricular or ocular use.

Liquid sterile preparation consisting of an emulsion intended for use in the preparation of an emulsion for injection.

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.

Semi-solid preparation consisting of a gel intended for intrauterine use.

Liquid preparation consisting of an aqueous solution intended for transdermal delivery by means of iontophoresis.

Liquid preparation consisting of a sterile solvent containing no active substances, intended for reconstitution of a usually freeze-dried powder for eye drops.

Solid, usually single-dose preparation consisting of a tablet, usually uncoated, intended to be dispersed in the specified liquid to obtain a rectal suspension.

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.

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.

Not assigned

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.

Solid preparation consisting of an uncoated tablet intended to be dissolved in water to obtain a mouthwash.

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.

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.

Solid, usually single-dose preparation consisting of a tablet, usually uncoated, intended to be dissolved in the specified liquid to obtain a rectal solution.

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.

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.

Solid preparation consisting of one or more powders intended to be mixed with the specified liquid or gel to obtain an endocervical gel.

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.

Liquid sterile preparation consisting of a solution intended for irrigation of one or more internal structures of the eye, for example during surgical procedures.

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.

Liquid sterile preparation consisting of an oil-in-water emulsion intended to be introduced, usually in large volumes, usually into the circulating blood stream.

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.

Liquid preparation consisting of a solution intended for nasal or oromucosal application. 'Nasal/oromucosal spray, solution' and 'Nasal spray, solution/oromucosal solution' are excluded.

Liquid sterile preparation consisting of a solution containing an allergen product intended for diagnostic use in a skin-scratch test.

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.

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).

Liquid preparation consisting of a suspension intended for cleaning the sinuses.

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.

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.

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.

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.

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.

Solid preparation consisting of a sponge impregnated with active substance(s); different routes of administration are possible.

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.

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.

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.

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.

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.

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.

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.

Liquid sterile preparation consisting of a solution intended to be instilled as drops into an internal part of the eye.

Liquid sterile preparation consisting of a solution intended for the preparation of a sealant.

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.

Liquid sterile single-dose or multidose preparation consisting of an emulsion intended for administration by injection or infusion.

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.

Liquid sterile preparation consisting of a solution intended for intraperitoneal use. 'Solution for peritoneal dialysis' is excluded.

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.

Liquid preparation consisting of a suspension intended for administration to the stomach or duodenum by means of a suitable applicator.

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.

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.

Liquid single-dose or multidose preparation consisting of a suspension intended for oromucosal use.

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.

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.

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).

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.

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.

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.

Solid single-dose preparation, usually rod-shaped or conical, intended for nasal use, usually to obtain a local effect.

Liquid sterile single-dose or multidose preparation consisting of a solution intended for administration by injection or infusion.

Solid flexible preparation containing an allergen product intended for provocation testing by application to the skin.

Liquid preparation consisting of a solution containing an allergen intended for provocation testing by the nasal, ocular or bronchial routes.

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.

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.

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.

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.

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.

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.

Liquid preparation consisting of a suspension intended for oral or rectal use.

Liquid sterile single-dose or multidose preparation consisting of an aqueous solution intended for washing or bathing the eye.

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.

Liquid, more or less viscous, sterile preparation intended for use as tissue glue.

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.

Liquid, usually multidose preparation consisting of a solution intended for gingival use.

Semi-solid single-dose or multidose preparation consisting of a gel intended for gingival use to obtain a local effect.

Solid single-dose preparation contained in a soft shell to be chewed or sucked to obtain a local effect in the oral cavity.

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.

Liquid, usually multidose preparation consisting of an emulsion intended for sublingual use. Sublingual sprays are usually presented in pressurised containers with a metering valve.

Liquid single-dose or multidose preparation consisting of a suspension intended for nasal use by means of a suitable applicator.

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.

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.

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.

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.

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).

Solid preparation consisting of one or more powders, including freeze-dried powders, intended for use in the preparation of a dental cement.

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.

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.

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.

Solid preparation consisting of modified-release granules intended to be dispersed in the specified liquid to obtain a modified-release oral suspension. The generic term 'Modified-release granules for oral suspension' is used only when the more-specific terms 'Gastro-resistant granules for oral suspension' or 'Prolonged-release granules for oral suspension' do not apply.

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.

Semi-solid single-dose or multidose preparation intended for oral use, consisting of a paste to be swallowed after administration to the oral cavity.

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.

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.

Liquid sterile single-dose or multidose preparation consisting of a solution intended for administration by injection.

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.

A gas packaged under pressure, which is partially liquid (gas over liquid) at -50 °C.

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.

Liquid sterile preparation consisting of a suspension intended for use in the preparation of an emulsion for injection.

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.

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.

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.

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.

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.

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.

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.

Liquid sterile preparation intended to be diluted in the specified liquid in order to obtain an emulsion for injection.

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.

Liquid preparation intended to be diluted in the specified liquid to obtain an oral/rectal solution.

Liquid preparation intended to be diluted in the specified liquid to obtain an oral solution.

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.

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.

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.

Liquid sterile preparation intended to be diluted in the specified liquid to obtain an emulsion for infusion.

Liquid sterile preparation intended to be diluted in the specified liquid to obtain a solution for peritoneal dialysis.

Semi-solid preparation consisting of an ointment intended for cutaneous or nasal use.

Liquid preparation intended to be diluted in the specified liquid to obtain an intravesical solution.

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.

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.

Liquid preparation consisting of a solution intended for cutaneous use or intended to be diluted in the specified liquid to obtain an oromucosal solution.

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.

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.

Liquid preparation consisting of a solution intended for use as a nasal spray or an oromucosal solution.

Liquid sterile preparation intended to be diluted in the specified liquid to obtain a solution for intraocular irrigation.

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).

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.

Liquid sterile preparation intended to be diluted in the specified liquid to obtain a suspension for injection.

Liquid preparation intended to be diluted in the specified liquid to obtain a nebuliser solution.

Solid preparation consisting of one or more powders intended to be mixed with the specified liquid or gel to obtain a gingival gel.

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.

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.

Solid sterile preparation consisting of one or more powders intended to be mixed with the specified liquid or paste to obtain an implantation paste.

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.

Liquid preparation consisting of a suspension intended for use in the preparation of an oral suspension.

Liquid preparation intended to be diluted in the specified liquid to obtain an oromucosal solution.

Liquid preparation consisting of a small-volume suspension intended for intravesical use by means of a suitable applicator.

Solid, usually single-dose preparation consisting of a tablet, usually uncoated, intended to be dissolved in the specified liquid to obtain a cutaneous solution.

Solid preparation consisting of one or more powders, including freeze-dried powders, intended to be dissolved in the specified liquid to obtain a vaginal solution.

Solid single-dose preparation consisting of a tablet intended for oral use, in which one or more ingestible sensors are embedded. The sensor is usually not digested, and is usually intended for use with external diagnostic equipment to which it can transmit data such as physiological and behavioural measurements.

Solid single-dose preparation made by freeze-drying of a liquid or semi-solid preparation, intended for sublingual use.

Liquid sterile preparation intended to be diluted in the specified liquid to obtain a dispersion for injection.

Non-sterile, liquid preparation consisting of a solution intended for cutaneous or oromucosal use; it is not intended for use on injured skin.

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.

Liquid, usually multidose preparation consisting of a solution of the active substance in a suitable vehicle intended for cutaneous use.

Liquid, usually multidose preparation consisting of a suspension of fine particles in a suitable vehicle intended for cutaneous use.

Solid, usually multidose preparation consisting of a powder intended for cutaneous use. Cutaneous spray, powder is excluded.

Semi-solid single-dose or multidose preparation containing a large proportion of finely divided solids dispersed in the basis, intended for cutaneous use.

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.

Liquid preparation consisting of a solution intended for vaginal use by means of a suitable applicator in order to obtain a local effect.

Liquid preparation intended to be diluted in the specified liquid to obtain a rectal solution.

Liquid sterile preparation intended to be diluted in the specified liquid to obtain a solution for injection.

Liquid sterile single-dose or multidose preparation consisting of a suspension intended for administration by injection.

Liquid sterile preparation consisting of an aqueous solution intended to be introduced, usually in large volumes, usually into the circulating blood stream.

Liquid sterile preparation consisting of an aqueous solution to be mixed with extracorporeal blood.

Liquid preparation to be applied to dentures to form a lacquer by evaporation of the volatile solvent.

Liquid preparation consisting of an aqueous solution intended to be diluted in water to obtain a gargle.

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.

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.

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.

Solid discoid preparation consisting of a wafer enclosing a unit dose intended for oral use.

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).

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.

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.

Solid single-dose preparation consisting of a tablet intended to be dispersed in the specified liquid before being swallowed.

Solid single-dose preparation consisting of an uncoated tablet intended to be chewed before being swallowed. Chewable tablets are intended for oral administration.

Solid preparation consisting of one or more powders intended for administration on teeth and gums.

Liquid, usually multidose preparation consisting of a suspension intended for administration on teeth and gums.

Semi-solid, usually multidose preparation consisting of a hydrophilic gel intended for administration on teeth and gums by rubbing.

Liquid, usually multidose preparation consisting of an emulsion intended for cutaneous use.

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.

Liquid, usually multidose preparation consisting of a solution intended for administration on teeth and gums.

Liquid, usually multidose preparation consisting of an emulsion intended for administration on to the teeth and the gums.

Liquid, usually multidose preparation consisting of a liquid active substance per se, intended for cutaneous use.

Liquid preparation intended to be diluted in the specified liquid to obtain a cutaneous solution.

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.

Solid, semi-solid or liquid preparation to be added to the bath water.

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.

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.

Liquid preparation intended to be diluted in the specified liquid to obtain an oral suspension.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Liquid preparation intended to be diluted in the specified liquid to obtain a cutaneous spray emulsion.

Liquid sterile preparation intended to be diluted in the specified liquid to obtain a solution for injection/infusion.

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.

Solid preparation consisting of a single- or multilayer sheet of suitable material(s) intended for sublingual use to obtain a systemic effect.

Liquid sterile preparation consisting of a suspension intended for administration by injection; the active substance(s) are released over an extended period of time.

Liquid preparation consisting of a solution intended for use in the preparation of a dental cement.

Liquid preparation consisting of an emulsion intended for urethral use by means of a suitable applicator.

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.

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.

Liquid preparation consisting of an aqueous solution intended for intravesical use by means of a suitable applicator. 'Bladder irrigation' is excluded.

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.

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. The thickness of the coating is greater than that of film-coated granules. 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).

Semi-solid preparation intended for application in or on teeth, which subsequently hardens to form a seal or bond.

Liquid single-dose or multidose preparation consisting of a suspension intended for oral use, showing a slower release of the active substance(s) than that of a conventional-release oral suspension. This deliberate modification is achieved by a special formulation design and/or manufacturing method. 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.

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).

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.

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.

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.

Sterile liquid preparation consisting of sterilised water or an aqueous solution intended for irrigation of the urinary bladder.

Liquid sterile preparation intended to be diluted in the specified liquid to obtain a dispersion for infusion.

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. It shows a slower release of the active substance(s) than that of a conventional-release pessary. Prolonged release is achieved by a special formulation design and/or manufacturing method.

Liquid sterile preparation consisting of a solution intended for use as ear drops, eye drops or nasal drops.

Semi-solid preparation consisting of an ointment intended for urethral use by means of a suitable applicator.

Liquid sterile preparation consisting of an emulsion intended for use in the preparation of a suspension for injection.

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.

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.

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.

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.

Semi-solid preparation consisting of a gel intended for endocervical use by means of a suitable applicator.

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.

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; the active substance(s) are released over an extended period of time. To be used only when 'Prolonged-release emulsion for injection' is not appropriate. Solid suspension preparations are excluded.

Liquid preparation consisting of an aqueous suspension intended for instillation to the trachea and/or bronchi. Preparations for inhalation use are excluded.

Liquid sterile preparation consisting of a solution intended to be administered onto a wound, including surgical wounds; the active substance(s) are released over an extended period of time.

Solid preparation intended for oral use, consisting of granules coated with a thin polymeric film that dissolves within a few minutes in the gastrointestinal fluid. Film-coated granules are intended for oral use to release active substance(s) at a rate that is not significantly delayed compared to that of the uncoated granules.,Solid preparation intended for oral use, consisting of granules coated with a thin polymeric film that dissolves within a few minutes in the gastrointestinal fluid. Film-coated granules are intended for oral use to release active substance(s) at a rate, which is not significantly delayed compared to that of the uncoated granule.

Liquid single-dose or multidose preparation consisting of a suspension intended for oral use, showing a rate, a place and/or a time of release of the active substance(s) that is different from that of a conventional-release oral suspension. This deliberate modification is achieved by a special formulation design and/or manufacturing method. The generic term 'Modified-release oral suspension' is used only when the more-specific terms 'Gastro-resistant oral suspension' or 'Prolonged-release oral suspension' do not apply. 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.

Solid preparation consisting of one or more powders, including freeze-dried powders, intended to be dissolved in the specified liquid to obtain a mouthwash.

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.

Liquid sterile preparation consisting of an aqueous solution intended for irrigation of the stomach.

Liquid preparation consisting of a solution intended for use as a gargle or a mouthwash.

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.

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.

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.

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.

Solid preparation consisting of granules intended to be dispersed in the specified liquid to obtain an oral/rectal suspension.

Liquid preparation consisting of a solution intended for oral or rectal use.

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.

Solid preparation consisting of granules intended to be dissolved in the specified liquid to obtain an oral drops solution.

Liquid sterile preparation consisting of a solution intended for intravesical use or for administration by injection.

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.

Liquid preparation consisting of a solution intended for use as a gargle or a nasal wash.

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.

Liquid preparation consisting of a solution intended for spraying onto the laryngopharynx for a local effect.

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.

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.

Liquid preparation consisting of a solution intended for administration to the laryngopharynx for a local effect, other than by spraying.

Whole, live, medicinal larvae, usually of a species of fly such as Lucilla sericata (common greenbottle fly), provided in an appropriate container such as a mesh bag, intended to be applied to a wound and covered with an appropriate dressing in order to allow debridement of necrotic tissue over a specified period of time (usually a few days). The larvae secrete enzymes into the wound, liquefying the necrotic tissue, and ingest the resulting material.

Whole, live, medicinal leech, usually of the Hirudo genus (e.g. Hirudo medicinalis, Hirudo verbana), usually intended to be applied to the skin in order to restore or improve local blood flow or to provide other local effects. After attaching itself to the host, the leech creates an incision in the skin and secretes saliva containing a variety of active substances (e.g. anaesthetics, anticoagulants, anti-inflammatories, vasodilators) that allow it to feed on the blood of the host.

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.

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.

Assembly of components intended for transdermal delivery driven by external forces (e.g. electric current, chemical reaction,...). Transdermal patch is excluded.

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.

Liquid preparation consisting of an emulsion intended for vaginal use by means of a suitable applicator in order to obtain a local effect.

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.

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.

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.

Liquid preparation consisting of a suspension intended for vaginal use by means of a suitable applicator in order to obtain a local effect.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Sterile single-dose preparation consisting of a hydrophilic gel intended for injection into a specific tissue or organ.

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.

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.

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.

Semi-solid preparation consisting of a gel intended for urethral use by means of a suitable applicator.

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.

Liquid preparation consisting of a solution intended for administration to the stomach or duodenum by means of a suitable applicator.

A radionuclide produced for the radio-labelling of another substance prior to administration.

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.

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.

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.

Liquid preparation consisting of an emulsion intended for administration to the stomach or duodenum by means of a suitable applicator.

Solid preparation consisting of a piece of absorbent material impregnated with a liquid preparation. Impregnated cutaneous swab is excluded.

Solid preparation consisting of a biodegradable or non-degradable thread impregnated with active substance(s).

Semi-solid preparation consisting of a gel intended for intestinal use.

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.

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.

Solid preparation consisting of a tablet intended to be dissolved in water to obtain a gargle.

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.

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.

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.

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.

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.

Solid preparation consisting of one or more powders intended to be dissolved in water to obtain a gargle.

Solid single-dose preparation with a gum-like consistency, intended to be sucked or chewed before being swallowed. Medicated chewing gum is excluded.

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.

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.

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.

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.

Solid preparation consisting of one or more powders intended for administration within the tooth socket/periodontal membrane.

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.

Liquid preparation consisting of a sterile solvent containing no active substances, intended for reconstitution of a usually freeze-dried powder for eye lotion.

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.

Semi-solid, usually multidose preparation consisting of a hydrophilic paste intended to be rubbed onto the teeth.

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.

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.

Liquid preparation to be applied to the nails to form a lacquer by evaporation of the volatile solvent.

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).

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.

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.

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.

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’.

Liquid single-dose or multidose, delayed-release preparation consisting of a suspension intended for oral use. The preparation is intended to resist the gastric fluid and release the active substance(s) in the intestinal fluid. 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.

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.

Solid preparation consisting of a single- or multilayer sheet of suitable material(s) intended for oromucosal use. It is applied to the oral cavity or onto specific parts of the oral cavity, usually to obtain a systemic effect. Where a preparation is intended for use only at a single specific part of the oral cavity, the appropriate specific term (e.g. Buccal film, Sublingual film) is used instead.

Solid single-dose preparation consisting of a small bag made of a suitable material containing a preparation such as a powder; it is intended to be placed in 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.

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.

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.

Liquid preparation consisting of a solution intended for oromucosal or laryngopharyngeal use. 'Oromucosal/laryngopharyngeal solution/spray, solution' is excluded.

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.

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.

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.

Solid, usually single-dose preparation consisting of a tablet, usually uncoated, intended to be dissolved in the specified liquid to obtain a vaginal solution.

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.

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.

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.

Solid preparation consisting of a piece of absorbent material impregnated usually with a liquid preparation, intended to be applied to the skin for a limited period of time with one or more wiping motions, and which may be attached to an application device such as a stick. Impregnated pad is excluded.

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.

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.

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.

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.

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.

Liquid preparation consisting of a suspension intended for use in the preparation of a spray.

Liquid preparation consisting of a solution intended for use in the preparation of a spray.

Eye drops, prolonged-release solution