ภาคผนวกที่ 1
ตารางแสดงตัวอย่างรูปแบบของยา (Dosage form) ตามมาตรฐาน EDQM
| No. | Dosage form | Definition |
| 1 | bath additive | Solid, semi-solid or liquid preparation to be added to the bath water. |
| 2 | capsule, hard | 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. |
| 3 | capsule, soft | 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. |
| 4 | chewable tablet | Solid single-dose preparation consisting of an uncoated tablet intended to be chewed before being swallowed. Chewable tablets are intended for oral administration. |
| 5 | coated tablet | 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). |
| 6 | collodion | 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. |
| 7 | concentrate and solvent for solution for infusion | Sterile concentrate and sterile solvent intended for the preparation of a solution for infusion by diluting the concentrate with the solvent. |
| 8 | concentrate for cutaneous solution | Liquid preparation intended to be diluted in the specified liquid to obtain a cutaneous solution. |
| 9 | concentrate for gargle | Liquid preparation consisting of an aqueous solution intended to be diluted in water to obtain a gargle. |
| 10 | concentrate for haemodialysis solution | 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. |
| 11 | concentrate for oral solution | Liquid preparation intended to be diluted in the specified liquid to obtain an oral solution. |
| 12 | concentrate for solution for infusion | 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. |
| 13 | concentrate for solution for injection | Liquid sterile preparation intended to be diluted in the specified liquid to obtain a solution for injection. |
| 14 | concentrate for solution for injection/infusion | Liquid sterile preparation intended to be diluted in the specified liquid to obtain a solution for injection/infusion. |
| 15 | cream | 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. |
| 16 | cutaneous emulsion | Liquid, usually multidose preparation consisting of an emulsion intended for cutaneous use. |
| 17 | cutaneous liquid | Liquid, usually multidose preparation consisting of a liquid active substance per se, intended for cutaneous use. |
| 18 | cutaneous paste | Semi-solid single-dose or multidose preparation containing a large proportion of finely divided solids dispersed in the basis, intended for cutaneous use. |
| 19 | cutaneous patch | 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. |
| 20 | cutaneous powder | Solid, usually multidose preparation consisting of a powder intended for cutaneous use. Cutaneous spray, powder is excluded. |
| 21 | cutaneous solution | Liquid, usually multidose preparation consisting of a solution of the active substance in a suitable vehicle intended for cutaneous use. |
| 22 | cutaneous spray, ointment | 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. |
| 23 | cutaneous spray, solution | 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. |
| 24 | cutaneous stick | 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. |
| 25 | cutaneous suspension | Liquid, usually multidose preparation consisting of a suspension of fine particles in a suitable vehicle intended for cutaneous use. |
| 26 | dental gel | Semi-solid, usually multidose preparation consisting of a hydrophilic gel intended for administration on teeth and gums by rubbing. |
| 27 | dental paste | 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. |
| 28 | dental solution | Liquid, usually multidose preparation consisting of a solution intended for administration on teeth and gums. |
| 29 | dental suspension | Liquid, usually multidose preparation consisting of a suspension intended for administration on teeth and gums. |
| 30 | dispersible tablet | Solid single-dose preparation consisting of a tablet intended to be dispersed in the specified liquid before being swallowed. |
| 31 | ear drops, solution | 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. |
| 32 | ear drops, suspension | 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. |
| 33 | ear powder | 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. |
| 34 | ear wash, solution | 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. |
| 35 | ear/eye drops, solution | Liquid sterile preparation consisting of a solution intended for use as ear drops or eye drops. |
| 36 | effervescent granules | 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. |
| 37 | effervescent powder | 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. |
| 38 | effervescent tablet | 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. |
| 39 | emulsion for infusion | Liquid sterile preparation consisting of an oil-in-water emulsion intended to be introduced, usually in large volumes, usually into the circulating blood stream. |
| 40 | emulsion for injection | Liquid sterile single-dose or multidose preparation consisting of an emulsion intended for administration by injection. |
| 41 | emulsion for injection/infusion | Liquid sterile single-dose or multidose preparation consisting of an emulsion intended for administration by injection or infusion. |
| 42 | endotracheopulmonary instillation, powder for solution | 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. |
| 43 | endotracheopulmonary instillation, suspension | Liquid preparation consisting of an aqueous suspension intended for instillation to the trachea and/or bronchi. Preparations for inhalation use are excluded. |
| 44 | eye drops, emulsion | 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. |
| 45 | eye drops, solution | 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. |
| 46 | eye drops, suspension | 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. |
| 47 | eye drops, tablet and solvent for solution | – |
| 48 | eye gel | 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. |
| 49 | eye lotion | Liquid sterile single-dose or multidose preparation consisting of an aqueous solution intended for washing or bathing the eye. |
| 50 | eye ointment | 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. |
| 51 | film-coated tablet | 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. |
| 52 | gargle | 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. |
| 53 | gargle/mouthwash | Liquid preparation consisting of a solution intended for use as a gargle or a mouthwash. |
| 54 | gastro-resistant capsule, hard | 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. |
| 55 | gastro-resistant granules | 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. |
| 56 | gastro-resistant granules for oral suspension | Solid preparation consisting of gastro-resistant granules intended to be dispersed in the specified liquid to obtain a gastro-resistant oral suspension. |
| 57 | gastro-resistant tablet | 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. |
| 58 | gel | 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. |
| 59 | gel for injection | Sterile single-dose preparation consisting of a hydrophilic gel intended for injection into a specific tissue or organ. |
| 60 | gingival gel | Semi-solid single-dose or multidose preparation consisting of a gel intended for gingival use to obtain a local effect. |
| 61 | gingival solution | Liquid, usually multidose preparation consisting of a solution intended for gingival use. |
| 62 | granules | 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. |
| 63 | granules for oral solution | 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. |
| 64 | granules for oral suspension | 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. |
| 65 | granules for syrup | 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. |
| 66 | implant | 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. |
| 67 | implantation chain | 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. |
| 68 | impregnated dressing | 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. |
| 69 | inhalation powder | 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. |
| 70 | inhalation powder, hard capsule | 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. |
| 71 | inhalation powder, pre-dispensed | 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. |
| 72 | inhalation 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. |
| 73 | inhalation vapour, liquid | 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. |
| 74 | inhalation vapour, solution | 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. |
| 75 | intestinal gel | Semi-solid preparation consisting of a gel intended for intestinal use. |
| 76 | intrauterine delivery system | Solid single-dose delivery system intended for intrauterine use that releases its contents of active substance(s) over an extended period of time. |
| 77 | intravesical solution | Liquid preparation consisting of an aqueous solution intended for intravesical use by means of a suitable applicator. ‘Bladder irrigation’ is excluded. |
| 78 | intravitreal implant in applicator | Medicinal product consisting of an intravitreal implant presented in an applicator. |
| 79 | irrigation solution | 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. |
| 80 | lozenge | 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. |
| 81 | medicated chewing-gum | 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. |
| 82 | medicated plaster | 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. |
| 83 | modified-release capsule, hard | 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. |
| 84 | modified-release tablet | 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. |
| 85 | mouthwash | 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. |
| 86 | nasal drops, powder for solution | 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. |
| 87 | nasal drops, solution | Liquid single-dose or multidose preparation consisting of a solution intended for nasal use by means of a suitable applicator. |
| 88 | nasal gel | 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. |
| 89 | nasal spray, powder for solution | 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. |
| 90 | nasal spray, solution | 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. |
| 91 | nasal spray, suspension | 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. |
| 92 | nebuliser 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. |
| 93 | nebuliser suspension | 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. |
| 94 | ointment | 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. |
| 95 | oral drops, emulsion | 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. |
| 96 | oral drops, liquid | 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. |
| 97 | oral drops, solution | 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. |
| 98 | oral drops, suspension | 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. |
| 99 | oral emulsion | 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. |
| 100 | oral gel | 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. |
| 101 | oral liquid | 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. |
| 102 | oral lyophilisate | 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. |
| 103 | oral paste | Semi-solid single-dose or multidose preparation intended for oral use, consisting of a paste to be swallowed after administration to the oral cavity. |
| 104 | oral powder | 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. |
| 105 | oral solution | 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. |
| 106 | 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. |
| 107 | oral/rectal suspension | Liquid preparation consisting of a suspension intended for oral or rectal use. |
| 108 | orodispersible 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. |
| 109 | oromucosal drops | 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. |
| 110 | oromucosal gel | 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. |
| 111 | oromucosal paste | 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. |
| 112 | oromucosal solution | Liquid single-dose or multidose preparation consisting of a solution intended for oromucosal use. |
| 113 | oromucosal spray, solution | 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. |
| 114 | pastille | 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. |
| 115 | pessary | 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. |
| 116 | powder and solvent for oral solution | Powder (including freeze-dried powder) and solvent intended for the preparation of an oral solution by dissolving the powder in the solvent. |
| 117 | powder and solvent for oral suspension | Powder (including freeze-dried powder) and solvent intended for the preparation of an oral suspension by dispersing the powder in the solvent. |
| 118 | powder and solvent for prolonged-release suspension for injection | Sterile powder (including freeze-dried powder) and sterile solvent intended for the preparation of a prolonged-release suspension for injection by dispersing the powder in the solvent. |
| 119 | powder and solvent for solution for infusion | Sterile powder (including freeze-dried powder) and sterile solvent intended for the preparation of a solution for infusion by dissolving the powder in the solvent. |
| 120 | powder and solvent for solution for injection | Sterile powder (including freeze-dried powder) and sterile solvent intended for the preparation of a solution for injection by dissolving the powder in the solvent. |
| 121 | powder and solvent for solution for injection/infusion | Sterile powder (including freeze-dried powder) and sterile solvent intended for the preparation of a solution for injection/infusion by dissolving the powder in the solvent. |
| 122 | powder and solvent for suspension for injection | Sterile powder (including freeze-dried powder) and sterile solvent intended for the preparation of a suspension for injection by dispersing the powder in the solvent. |
| 123 | powder and suspension for suspension for injection | Sterile powder (including freeze-dried powder) and sterile suspension, both of which contain active substance(s), intended for the preparation of a suspension for injection by dispersing the powder in the suspension. |
| 124 | powder for concentrate for 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 dispersion for infusion, which must subsequently be diluted before administration as a dispersion for infusion. |
| 125 | powder for concentrate for solution for infusion | 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. |
| 126 | powder for cutaneous 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 concentrate for solution for infusion, which must subsequently be diluted before administration as a solution for infusion. |
| 127 | powder for oral solution | 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. |
| 128 | powder for oral suspension | 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. |
| 129 | powder for oral/rectal suspension | 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. |
| 130 | powder for rectal solution | 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. |
| 131 | powder for solution for infusion | 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. |
| 132 | powder for solution for injection | 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. |
| 133 | powder for solution for injection/infusion | 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. |
| 134 | powder for suspension for infusion | 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 |
| 135 | powder for suspension for injection | 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. |
| 136 | powder for syrup | 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. |
| 137 | pressurised inhalation, solution | 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. |
| 138 | pressurised inhalation, suspension | 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. |
| 139 | prolonged-release capsule, hard | 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. |
| 140 | prolonged-release granules | 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. |
| 141 | prolonged-release suspension for injection | Liquid sterile preparation consisting of a suspension intended for administration by injection; the active substance(s) are released over an extended period of time. |
| 142 | prolonged-release tablet | 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. |
| 143 | rectal foam | 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. |
| 144 | rectal solution | 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. |
| 145 | rectal suspension | 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. |
| 146 | shampoo | 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. |
| 147 | solution for cardioplegia | 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. |
| 148 | solution for haemodialysis/ haemofiltration | Liquid sterile preparation consisting of a solution intended for use as a solution for haemodialysis or a solution for haemofiltration. |
| 149 | solution for infusion | Liquid sterile preparation consisting of an aqueous solution intended to be introduced, usually in large volumes, usually into the circulating blood stream. |
| 150 | solution for injection | Liquid sterile single-dose or multidose preparation consisting of a solution intended for administration by injection. |
| 151 | solution for injection/infusion | Liquid sterile single-dose or multidose preparation consisting of a solution intended for administration by injection or infusion. |
| 152 | solution for organ preservation | 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. |
| 153 | solution for peritoneal dialysis | 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. |
| 154 | solution for sealant | Liquid sterile preparation consisting of a solution intended for the preparation of a sealant. |
| 155 | sublingual spray, solution | Liquid, usually multidose preparation consisting of a solution intended for sublingual use. Sublingual sprays are usually presented in pressurised containers with a metering valve. |
| 156 | sublingual tablet | 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. |
| 157 | suppository | 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. |
| 158 | suspension and effervescent granules for oral suspension | Suspension and effervescent granules, both containing active ingredients, intended for the preparation of an oral suspension by dissolving or dispersing the granules in the suspension. |
| 159 | suspension and solution for spray | Suspension and solution for spray |
| 160 | suspension for injection | Liquid sterile single-dose or multidose preparation consisting of a suspension intended for administration by injection. |
| 161 | syrup | 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. |
| 162 | tablet | 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). |
| 163 | transdermal patch | 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. |
| 164 | transdermal 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. |
| 165 | vaginal capsule, hard | 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. |
| 166 | vaginal capsule, soft | 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. |
| 167 | vaginal cream | 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. |
| 168 | vaginal delivery system | 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. |
| 169 | vaginal gel | 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. |
| 170 | vaginal tablet | 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. |