TANZANIA FOOD AND DRUGS AUTHORITY

Transcription

1 Doc. No. TFDA/DMC/HVR/G/001 TANZANIA FOOD AND DRUGS AUTHORITY GUIDELINES ON LIST OF STANDARD TERMS FOR PHARMACEUTICAL DOSAGE FORMS AND ROUTES OF ADMINISTRATION (Made under Section 52 (1) of the Tanzania Food, Drugs and Cosmetics Act, 2003) First Edition January, 2015 P. O. Box 77150, EPI Mabibo, Off Mandela Road, Dar es Salaam, Tanzania Tel: / / ; Fax: Website:

2 TABLE OF CONTENTS 1.1 Scope Guidance for use Definitions Pharmaceutical form Dosage form:... 4 a) Form of presentation:... 4 b) Form of administration Combined term Pharmaceutical forms Routes of administration Procedure for the addition or modification of terms in the list of standard terms Pharmaceutical forms and short terms Routes of Administration

3 1. INTRODUCTION AND GUIDANCE FOR USE 1.1 Scope This list of standard terms for pharmaceutical dosage forms and routes of administration will assist in knowing all dosage forms used and routes used, accurate dose, protected dosage forms e.g. coated tablets, sealed ampoules, masked taste and odour, placement of drugs within body tissues, sustained release medication, controlled release medication, optimal drug action, insertion of drugs into body cavities (rectal, vaginal) and Use of desired vehicle for insoluble drugs. It has the double purpose to bring information to user (patient/prescriber) and distinguishing pharmaceutical products having the same trade/generic name. Because of labelling purposes it is imperative that any Standard Term and combination of Standard Terms is constructed with a view to the patient. However, information on the container and the route of administration need not always be included in the Standard Term but may appear elsewhere in the labelling, package leaflet and SmPC. 1.2 Guidance for use The List of Standard Terms covers dosage forms and routes of administration for the use in the marketing authorization application, Summary of Product Characteristics (SmPC), Patient Information leaflet and labelling of medicinal product for human use Definitions For the purposes of the Standard Terms, the following definitions apply Pharmaceutical form The pharmaceutical form may be: a) a dosage form; b) a combination of dosage forms; or c) a combination of dosage form(s) and route(s)/method(s) of administration and/or container/administration device. In the assessment of marketing authorization applications, pharmaceutical forms that differ only with respect to the containers/administration devices may not always be considered as different pharmaceutical forms. 3

4 Dosage form: The dosage form is the physical manifestation of a pharmaceutical product that contains the active ingredient(s) and/or excipient(s) that are intended to be delivered to the patient; it may refer to the form of presentation or the form of administration, which in some cases are identical. a) Form of presentation: The form of presentation is the dosage form of a pharmaceutical product as manufactured and, where applicable, before reconstitution; where reconstitution is required before administration to the patient, the term includes the eventual form of administration. Examples: Powder for solution for injection; Tablet b) Form of administration The form of administration is the dosage form of a pharmaceutical product as administered to the patient, after any necessary reconstitution has been carried out. Examples: Combined term Solution for injection; Tablet A combined term is a combination of existing Standard Terms or elements thereof that is constructed in order to properly characterize a pharmaceutical product; a combined term may be a combination of dosage forms, or a combination of dosage form(s) and route(s)/method(s) of administration and/or container/administration device. Examples: Powder and solution for solution for injection; Eye drops, solution in single-dose container Pharmaceutical forms The list of Standard Terms does not distinguish between pharmaceutical products as presented by the manufacturer (form of presentation) and pharmaceutical products as administered to the patient (form of administration). However, for a term representing a form of presentation such as Powder for solution for injection, the words for solution for injection indicate that a reconstitution is required, and that the resulting form of administration is solution for injection. 4

5 The label of the medicinal product may be too small to permit the inclusion of the Standard Term(s). In addition to the Standard Terms given in the Dosage forms section, a number of patient-friendly terms (generally shortened versions of existing terms), which may be used for labelling only, in case of space limitation, are also proposed. Where a term contains two or more dosage form elements, these elements are linked by and ; e.g. Powder and solvent for solution for injection If the same pharmaceutical form may be used in alternative ways, these ways are separated by /, e.g. Gargle/mouthwash, Chewable/dispersible tablet. In the case of a powder that is dissolved in a small amount of solvent before it is diluted in a larger volume to be infused and this dilution is mandatory for safety reasons, the term concentrate should appear in the pharmaceutical form (e.g. Powder for concentrate for solution for infusion ). If the powder that is dissolved in a small amount of solvent can either be administered as such or be further diluted before administration (i.e. no safety issue), there is no need to use the term concentrate (e.g. Powder for solution for infusion ). The term modified-release is not sufficiently precise for describing a particular product. A more specific term such as prolonged-release or gastro-resistant should be used, wherever applicable Routes of administration The route of administration indicates the part of the body on which, through which or into which the pharmaceutical product is to be introduced. The short terms proposed may be used for labelling only. Where several routes of administration are intended for a pharmaceutical product, the focus should be placed on the primary use for the creation of a standard term or a combination of standard terms, for example Oral use is sufficient as the primary use for a request of Oral/gastric/gastroenteral use Procedure for the addition or modification of terms in the list of standard terms 1.3 Pharmaceutical forms and short terms Standard terms BATH ADDITIVE BLADDER IRRIGATION BAR CHEWABLE BLOOD FRACTION MODIFIER 5 short terms BATH ADDITIVE BLADDER IRRIGATION BAR CHEWABLE BLOOD FRACTION MODIFIER

6 BUCCAL FILM BUCCAL TABLET CACHET CAPSULE CAPSULE, HARD SHELL CAPSULE, SOFT SHELL CHEWABLE CAPSULE, SOFT CHEWABLE TABLET COATED GRANULES IN SACHET COATED TABLET COLLODION COMPRESSED LOZENGE CONCENTRATE FOR FOR CUTANEOUS FOR FOR INJECTION FOR INJECTION/ FOR INJECTION CONCENTRATE FOR CUTANEOUS CONCENTRATE FOR CUTANEOUS SPRAY, EMULSION CONCENTRATE FOR DISPERSION FOR CONCENTRATE FOR EMULSION FOR CONCENTRATE FOR GARGLE CONCENTRATE FOR HAEMODIALYSIS CONCENTRATE FOR INTRAVESICAL USE CONCENTRATE FOR ORAL CONCENTRATE FOR ORAL CONCENTRATE FOR ORAL/RECTAL CONCENTRATE FOR RECTAL 6 BUCCAL FILM BUCCAL TABLET CACHET CAPSULE CAPSULE CAPSULE CHEWABLE CAPSULE CHEWABLE TABLET GRANULES TABLET COLLODION LOZENGE CONCENTRATE FOR FOR CUTANEOUS FOR FOR INJECTION FOR INJECTION/ FOR INJECTION CONCENTRATE FOR CUTANEOUS CONCENTRATE FOR CUTANEOUS SPRAY, EMULSION CONCENTRATE FOR DISPERSION FOR CONCENTRATE FOR EMULSION FOR CONCENTRATE FOR GARGLE CONCENTRATE FOR HAEMODIALYSIS CONCENTRATE FOR INTRAVESICAL USE CONCENTRATE FOR ORAL CONCENTRATE FOR ORAL CONCENTRATE FOR ORAL/RECTAL CONCENTRATE FOR RECTAL

7 CONCENTRATE FOR FOR CONCENTRATE FOR FOR INJECTION CONCENTRATE FOR FOR INJECTION/ CONCENTRATE FOR FOR PERITONEAL DIALYSIS CREAM CUTANEOUS EMULSION CUTANEOUS FOAM CUTANEOUS PASTE CUTANEOUS PATCH CUTANEOUS POWDER CUTANEOUS CUTANEOUS SPONGE CUTANEOUS /CONCENTRATE FOR OROMUCOSAL CUTANEOUS PATCH CUTANEOUS SPRAY CUTANEOUS SPRAY, EMULSION CUTANEOUS SPRAY, OINTMENT CUTANEOUS SPRAY, POWDER CUTANEOUS SPRAY, CUTANEOUS SPRAY, CUTANEOUS STICK CUTANEOUS CUTANEOUS OINTMENT DENTAL EMULSION DENTAL GEL DENTAL INSERT DENTAL LIQUID DENTAL PASTE DENTAL POWDER DENTAL DENTAL STICK DENTAL DENTURE LACQUER DISPERSIBLE TABLET DISPERSION DISPERSION FOR INJECTION EAR CREAM EAR DROPS STERILE CONCENTRATE STERILE CONCENTRATE STERILE CONCENTRATE CONCENTRATE FOR FOR PERITONEAL DIALYSIS CREAM CUTANEOUS LIQUID CUTANEOUS FOAM CUTANEOUS PASTE CUTANEOUS PATCH CUTANEOUS POWDER CUTANEOUS LIQUID CUTANEOUS SPONGE CUTANEOUS /CONCENTRATE FOR OROMUCOSAL CUTANEOUS PATCH CUTANEOUS SPRAY CUTANEOUS SPRAY CUTANEOUS SPRAY CUTANEOUS SPRAY CUTANEOUS SPRAY CUTANEOUS SPRAY CUTANEOUS STICK CUTANEOUS LIQUID CUTANEOUS OINTMENT DENTAL LIQUID DENTAL GEL DENTAL INSERT DENTAL LIQUID DENTAL PASTE DENTAL POWDER DENTAL LIQUID DENTAL STICK DENTAL LIQUID DENTURE LACQUER DISPERSIBLE TABLET DISPERSION DISPERSION FOR INJECTION EAR CREAM EAR DROPS 7

8 EAR DROPS, EMULSION EAR DROPS, POWDER AND SOLVENT FOR EAR DROPS, EAR DROPS, EAR DROPS, IN SINGLE- DOSE CONTAINER EAR GEL EAR OINTMENT EAR POWDER EAR SPRAY, EMULSION EAR SPRAY, EAR SPRAY, EAR STICK EAR TAMPON EAR WASH, EMULSION EAR WASH, EAR/EYE DROPS, EAR/EYE DROPS, EAR/EYE OINTMENT EAR/EYE/NASAL DROPS, EFFERVESCENT GRANULES EFFERVESCENT POWDER EFFERVESCENT TABLET EFFERVESCENT VAGINAL TABLET EMULSION FOR EMULSION FOR INJECTION EMULSION FOR INJECTION/ ENDOCERVICAL GEL ENDOSINUSIAL WASH, INSTILLATION INSTILLATION, POWDER AND SOLVENT FOR INSTILLATION, POWDER FOR INSTILLATION, INSTILLATION, ENEMA EYE CREAM EYE DROPS 8 EAR DROPS EAR DROPS, POWDER AND SOLVENT FOR EAR DROPS EAR DROPS EAR DROPS, IN SINGLE- DOSE CONTAINER EAR GEL EAR OINTMENT EAR POWDER EAR SPRAY EAR SPRAY EAR SPRAY EAR STICK EAR TAMPON EAR WASH EAR WASH EAR/EYE DROPS, EAR/EYE DROPS, EAR/EYE OINTMENT EAR/EYE/NASAL DROPS, EFFERVESCENT GRANULES EFFERVESCENT POWDER EFFERVESCENT TABLET EFFERVESCENT VAGINAL TABLET INJECTION INJECTION/ ENDOCERVICAL GEL ENDOSINUSIAL WASH, INSTILLATION INSTILLATION INSTILLATION INSTILLATION INSTILLATION ENEMA EYE CREAM EYE DROPS

9 EYE DROPS, EMULSION EYE DROPS, POWDER AND SOLVENT FOR EYE DROPS, POWDER AND SOLVENT FOR EYE DROPS, PROLONGED-RELEASE EYE DROPS, PROLONGED-RELEASE IN SINGLE-DOSE CONTAINER EYE DROPS, EYE DROPS, IN SINGLE- DOSE CONTAINER EYE DROPS, SOLVENT FOR RECONSTITUTION EYE DROPS, EYE DROPS, IN SINGLE- DOSE CONTAINER EYE GEL EYE GEL IN SINGLE-DOSE CONTAINER EYE LOTION EYE LOTION, SOLVENT FOR RECONSTITUTION EYE OINTMENT EYE OINTMENT IN SINGLE-DOSE CONTAINER FILM-COATED TABLET GARGLE GARGLE, POWDER FOR GARGLE, TABLET FOR GARGLE/MOUTHWASH GARGLE/NASAL WASH GAS AND SOLVENT FOR DISPERSION FOR INJECTION/ GASTROENTERAL EMULSION GASTROENTERAL LIQUID GASTROENTERAL GASTROENTERAL GASTRO-RESISTANT CAPSULE GASTRO-RESISTANT CAPSULE, HARD GASTRO-RESISTANT CAPSULE, SOFT GASTRO-RESISTANT GRANULES GASTRO-RESISTANT GRANULES FOR ORAL GASTRO-RESISTANT TABLET GEL 9 EYE DROPS, EMULSION EYE DROPS, POWDER AND SOLVENT FOR EYE DROPS, POWDER AND SOLVENT FOR EYE DROPS, PROLONGED-RELEASE EYE DROPS, PROLONGED-RELEASE IN SINGLE-DOSE CONTAINER EYE DROPS EYE DROPS, IN SINGLE- DOSE CONTAINER EYE DROPS, SOLVENT FOR RECONSTITUTION EYE DROPS EYE DROPS, IN SINGLE- DOSE CONTAINER EYE GEL EYE GEL IN SINGLE-DOSE CONTAINER EYE LOTION EYE LOTION, SOLVENT FOR RECONSTITUTION EYE OINTMENT EYE OINTMENT IN SINGLE-DOSE CONTAINER TABLET GARGLE GARGLE, POWDER FOR GARGLE, TABLET FOR GARGLE/MOUTHWASH GARGLE/NASAL WASH GAS AND SOLVENT FOR DISPERSION FOR INJECTION/ GASTROENTERAL LIQUID GASTROENTERAL LIQUID GASTROENTERAL LIQUID GASTROENTERAL LIQUID GASTRO-RESISTANT CAPSULE GASTRO-RESISTANT CAPSULE GASTRO-RESISTANT CAPSULE GASTRO-RESISTANT GRANULES GASTRO-RESISTANT GRANULES FOR ORAL GASTRO-RESISTANT TABLET GEL

10 GINGIVAL GEL GINGIVAL GEL GINGIVAL PASTE GINGIVAL PASTE GINGIVAL GINGIVAL GRANULES GRANULES GRANULES AND SOLVENT FOR ORAL GRANULES AND SOLVENT FOR ORAL GRANULES AND SOLVENT FOR GRANULES AND SOLVENT FOR FOR INJECTION FOR INJECTION GRANULES FOR ORAL GRANULES FOR ORAL GRANULES FOR ORAL SUSPESION GRANULES FOR ORAL SUSPESION GRANULES FOR ORAL/RECTAL GRANULES FOR ORAL/RECTAL GRANULES FOR ORAL DROPS, GRANULES FOR ORAL DROPS, GRANULES FOR RECTAL GRANULES FOR RECTAL GRANULES FOR SYRUP GRANULES FOR SYRUP GRANULES FOR VAGINAL GRANULES FOR VAGINAL IMPLANT IMPLANT IMPLANT IN PRE- IMPLANT IN PRE- IMPLANTATION CHAIN IMPLANTATION CHAIN IMPLANTATION TABLET IMPLANTATION TABLET IMPREGNATED DRESSING IMPREGNATED DRESSING IMPREGNATED PAD IMPREGNATED PAD IMPREGNATED PLUG IMPREGNATED PLUG INHALATION GAS INHALATION GAS INHALATION POWDER INHALATION POWDER INHALATION POWDER, HARD CAPSULE INHALATION POWDER INHALATION POWDER, PRE- INHALATION POWDER DISPENSED INHALATION POWDER, TABLET INHALATION POWDER INHALATION INHALATION INHALATION VAPOUR INHALATION VAPOUR INHALATION VAPOUR, CAPSULE INHALATION VAPOUR INHALATION VAPOUR, EFFERVESCENT TABLET INHALATION VAPOUR, EFFERVESCENT TABLET INHALATION VAPOUR, EMULSION INHALATION VAPOUR INHALATION VAPOUR, IMPREGNATED INHALATION VAPOUR PAD INHALATION VAPOUR, LIQUID INHALATION VAPOUR INHALATION VAPOUR, OINTMENT INHALATION VAPOUR INHALATION VAPOUR, POWDER INHALATION VAPOUR, POWDER INHALATION VAPOUR, INHALATION VAPOUR INHALATION VAPOUR, TABLET INHALATION VAPOUR 10

11 INJECTION INTESTINAL GEL INTRAPERITONEAL INTRAUTERINE DELIVERY SYSTEM INTRAUTERINE FOAM INTRAUTERINE LIQUID INTRAVESICAL IRRIGATION LOZENGE LIQUEFIED GAS FOR DENTAL USE LYOPHILISATE FOR OCULONASAL LYOPHILISATE FOR USE IN DRINKING WATER MEDICATED CHEWING-GUM MEDICATED NAIL LACQUER MEDICATED PLASTER MEDICATED SPONGE MEDICATED THREAD MEDICATED VAGINAL TAMPON MEDICINAL GAS, COMPRESSED MEDICINAL GAS, CRYOGENIC MEDICINAL GAS, LIQUEFIED MODIFIED-RELEASE CAPSULE, HARD MODIFIED-RELEASE CAPSULE, SOFT MODIFIED-RELEASE GRANULES MODIFIED-RELEASE GRANULES FOR ORAL MODIFIED-RELEASE TABLET MOUTHWASH MOUTHWASH, POWDER FOR MOUTHWASH, TABLET FOR MUCO-ADHESIVE BUCCAL TABLET NASAL CREAM NASAL DROPS NASAL DROPS, EMULSION NASAL DROPS, NASAL DROPS, IN SINGLE- DOSE CONTAINER NASAL DROPS, NASAL GEL NASAL OINTMENT NASAL POWDER INJECTION INTESTINAL GEL INTRAPERITONEAL INTRAUTERINE DELIVERY SYSTEM INTRAUTERINE FOAM INTRAUTERINE LIQUID INTRAVESICAL IRRIGATION LOZENGE LIQUEFIED GAS FOR DENTAL USE LYOPHILISATE FOR OCULONASAL LYOPHILISATE FOR USE IN DRINKING WATER MEDICATED CHEWING-GUM MEDICATED NAIL LACQUER MEDICATED PLASTER MEDICATED SPONGE MEDICATED THREAD MEDICATED VAGINAL TAMPON MEDICINAL GAS, COMPRESSED MEDICINAL GAS, CRYOGENIC MEDICINAL GAS, LIQUEFIED MODIFIED-RELEASE CAPSULE, HARD MODIFIED-RELEASE CAPSULE, SOFT MODIFIED-RELEASE GRANULES MODIFIED-RELEASE GRANULES FOR ORAL MODIFIED-RELEASE TABLET MOUTHWASH MOUTHWASH, POWDER FOR MOUTHWASH, TABLET FOR MUCO-ADHESIVE BUCCAL TABLET NASAL CREAM NASAL DROPS NASAL DROPS NASAL DROPS NASAL DROPS, IN SINGLE- DOSE CONTAINER NASAL DROPS NASAL GEL NASAL OINTMENT NASAL POWDER 11

12 NASAL SPRAY NASAL SPRAY, EMULSION NASAL SPRAY, POWDER FOR NASAL SPRAY, NASAL SPRAY, IN SINGLE- DOSE CONTAINER NASAL SPRAY, /OROMUCOSAL NASAL SPRAY, NASAL STICK NASAL WASH NASAL/OROMUCOSAL NASAL/OROMUCOSAL SPRAY, NEBULISER EMULSION NEBULISER LIQUID NEBULISER NEBULISER OINTMENT OPHTHALMIC INSERT OPHTHALMIC STRIP ORAL DROPS ORAL DROPS, EMULSION ORAL DROPS, GRANULES FOR ORAL DROPS, LIQUID ORAL DROPS, POWDER FOR ORAL DROPS, ORAL DROPS, ORAL EMULSION ORAL GEL ORAL GUM ORAL LIQUID ORAL LYOPHILISATE ORAL PASTE ORAL POWDER ORAL ORAL IN SINGLE-DOSE CONTAINER ORAL /CONCENTRATE FOR NEBULISER ORAL ORAL/RECTAL 12 NASAL SPRAY NASAL SPRAY NASAL POWDER NASAL SPRAY, NASAL SPRAY, IN SINGLE- DOSE CONTAINER NASAL SPRAY, /OROMUCOSAL NASAL SPRAY, NASAL STICK NASAL WASH NASAL/OROMUCOSAL NASAL/OROMUCOSAL SPRAY, NEBULISER LIQUID NEBULISER LIQUID NEBULISER LIQUID NEBULISER LIQUID OINTMENT OPHTHALMIC INSERT OPHTHALMIC STRIP ORAL DROPS ORAL DROPS ORAL DROPS, GRANULES FOR ORAL DROPS ORAL DROPS, POWDER FOR ORAL DROPS ORAL DROPS ORAL LIQUID ORAL GEL ORAL GUM ORAL LIQUID ORAL LYOPHILISATE ORAL PASTE ORAL POWDER ORAL LIQUID ORAL IN SINGLE-DOSE CONTAINER ORAL /CONCENTRATE FOR NEBULISER ORAL LIQUID ORAL/RECTAL LIQUID

13 ORAL/RECTAL ORODISPERSIBLE FILM ORODISPERSIBLE TABLET OROMUCOSAL CAPSULE OROMUCOSAL CREAM OROMUCOSAL DROPS OROMUCOSAL GEL OROMUCOSAL LIQUID OROMUCOSAL OINTMENT OROMUCOSAL PASTE OROMUCOSAL PATCH OROMUCOSAL POWDER IN POUCH OROMUCOSAL OROMUCOSAL SPRAY, EMULSION OROMUCOSAL SPRAY, OROMUCOSAL SPRAY, OROMUCOSAL OROMUCOSAL/LARYNGOPHARYNGEAL PASTILLE PERIODONTAL GEL PERIODONTAL INSERT PERIODONTAL POWDER PESSARY PILLULES PILLULES IN SINGLE-DOSE CONTAINER PLASTER FOR PROVOCATION TEST POUCH POULTICE FOR INJECTION CONCENTRATE FOR FOR CUTANEOUS DISPERSION FOR INJECTION EMULSION FOR INJECTION ENDOCERVICAL GEL ENDOSINUSIAL 13 ORAL/RECTAL LIQUID ORODISPERSIBLE FILM ORODISPERSIBLE TABLET OROMUCOSAL CAPSULE OROMUCOSAL CREAM OROMUCOSAL DROPS OROMUCOSAL GEL OROMUCOSAL LIQUID OROMUCOSAL OINTMENT OROMUCOSAL PASTE OROMUCOSAL PATCH OROMUCOSAL POWDER IN POUCH OROMUCOSAL LIQUID OROMUCOSAL SPRAY OROMUCOSAL SPRAY OROMUCOSAL SPRAY OROMUCOSAL LIQUID OROMUCOSAL/LARYNGOPHARYNGEAL PASTILLE PERIODONTAL GEL PERIODONTAL INSERT PERIODONTAL POWDER PESSARY PILLULES PILLULES IN SINGLE-DOSE CONTAINER PLASTER FOR PROVOCATION TEST POUCH POULTICE FOR INJECTION CONCENTRATE FOR FOR CUTANEOUS DISPERSION FOR INJECTION EMULSION FOR INJECTION ENDOCERVICAL GEL ENDOSINUSIAL

14 EPILESIONAL GINGIVAL GEL IMPLANTATION PASTE INSTILLATION FOR INTRAOCULAR USE INTRAVESICAL INTRAVESICAL NEBULISER ORAL ORAL PROLONGED-RELEASE FOR INJECTION SEALANT FOR FOR INJECTION FOR INJECTION IN CARTRIDGE FOR INJECTION IN PRE- FILLED PEN FOR INJECTION IN PRE- FOR INJECTION/ SKIN- PRICK TEST FOR INJECTION/ FOR INJECTION FOR INJECTION IN PRE- EPILESIONAL GINGIVAL GEL IMPLANTATION PASTE INSTILLATION FOR INTRAOCULAR USE INTRAVESICAL INTRAVESICAL NEBULISER ORAL ORAL PROLONGED-RELEASE FOR INJECTION SEALANT FOR FOR INJECTION FOR INJECTION IN CARTRIDGE FOR INJECTION IN PRE- FILLED PEN FOR INJECTION IN PRE- FOR INJECTION/ SKIN- PRICK TEST FOR INJECTION/ FOR INJECTION FOR INJECTION IN PRE- 14

15 POWDER AND FOR POWDER AND FOR FOR INJECTION FOR INJECTION POWDER FOR BLADDER IRRIGATION POWDER FOR BLADDER IRRIGATION POWDER FOR CONCENTRATE FOR POWDER FOR CONCENTRATE FOR DISPERSION FOR DISPERSION FOR POWDER FOR CONCENTRATE FOR POWDER FOR CONCENTRATE FOR INTRAVESICAL INTRAVESICAL POWDER FOR CONCENTRATE FOR POWDER FOR CONCENTRATE FOR FOR HAEMODIALYSIS FOR HAEMODIALYSIS POWDER FOR CONCENTRATE FOR POWDER FOR CONCENTRATE FOR FOR FOR POWDER FOR CONCENTRATE FOR POWDER FOR CONCENTRATE FOR FOR INJECTION/ FOR INJECTION/ POWDER FOR CUTANEOUS POWDER FOR CUTANEOUS POWDER FOR DENTAL POWDER FOR DENTAL POWDER FOR DISPERSION FOR POWDER FOR DISPERSION FOR POWDER FOR EPILESIONAL POWDER FOR EPILESIONAL POWDER FOR IMPLANTATION POWDER FOR IMPLANTATION POWDER FOR POWDER FOR POWDER FOR INJECTION POWDER FOR INJECTION POWDER FOR INTRAVESICAL POWDER FOR INTRAVESICAL POWDER FOR INTRAVESICAL POWDER FOR INTRAVESICAL / FOR INJECTION / FOR INJECTION POWDER FOR INTRAVESICAL POWDER FOR INTRAVESICAL POWDER FOR NEBULISER POWDER FOR NEBULISER POWDER FOR NEBULISER POWDER FOR NEBULISER POWDER FOR ORAL POWDER FOR ORAL POWDER FOR ORAL POWDER FOR ORAL POWDER FOR ORAL/RECTAL POWDER FOR ORAL/RECTAL POWDER FOR RECTAL POWDER FOR RECTAL POWDER FOR RECTAL POWDER FOR RECTAL POWDER FOR FOR POWDER FOR FOR POWDER FOR FOR POWDER FOR FOR INJECTION INJECTION POWDER FOR FOR POWDER FOR FOR INJECTION/ INJECTION/ POWDER FOR FOR POWDER FOR FOR 15

16 INTRAOCULAR IRRIGATION INTRAOCULAR IRRIGATION POWDER FOR FOR POWDER FOR FOR IONTOPHORESIS IONTOPHORESIS POWDER FOR FOR POWDER FOR FOR INJECTION INJECTION POWDER FOR SYRUP POWDER FOR SYRUP POWDER, DISPERSION AND SOLVENT FOR CONCENTRATE FOR DISPERSION FOR POWDER, DISPERSION AND SOLVENT FOR CONCENTRATE FOR DISPERSION FOR PRESSURISED INHALATION PRESSURISED INHALATION PRESSURISED INHALATION, PRESSURISED INHALATION, EMULSION EMULSION PRESSURISED INHALATION, PRESSURISED INHALATION, PRESSURISED INHALATION, PRESSURISED INHALATION, PROLONGED-RELEASE CAPSULE PROLONGED-RELEASE CAPSULE PROLONGED-RELEASE CAPSULE, PROLONGED-RELEASE CAPSULE HARD PROLONGED-RELEASE CAPSULE, PROLONGED-RELEASE CAPSULE SOFT PROLONGED-RELEASE GRANULES PROLONGED-RELEASE GRANULES PROLONGED-RELEASE GRANULES PROLONGED-RELEASE GRANULES FOR ORAL FOR ORAL PROLONGED-RELEASE PROLONGED-RELEASE FOR INJECTION FOR INJECTION PROLONGED-RELEASE PROLONGED-RELEASE FOR INJECTION IN PRE-FILLED FOR INJECTION IN PRE-FILLED SYRINGE SYRINGE PROLONGED-RELEASE TABLET PROLONGED-RELEASE TABLET RADIONUCLIDE GENERATOR RADIONUCLIDE GENERATOR RADIOPHARMACEUTICAL PRECURSOR RADIOPHARMACEUTICAL PRECURSOR RADIOPHARMACEUTICAL PRECURSOR, RADIOPHARMACEUTICAL PRECURSOR, RECTAL CAPSULE RECTAL CAPSULE RECTAL CREAM RECTAL CREAM RECTAL EMULSION RECTAL EMULSION RECTAL FOAM RECTAL FOAM RECTAL GEL RECTAL GEL RECTAL OINTMENT RECTAL OINTMENT RECTAL ENEMA RECTAL ENEMA RECTAL TAMPON RECTAL TAMPON SEALANT SEALANT SHAMPOO SHAMPOO SOLUBLE TABLET SOLUBLE TABLET 16

17 AND FOR FOR INJECTION IN PRE- FOR BLOOD FRACTION MODIFICATION FOR CARDIOPLEGIA FOR HAEMODIAFILTRATION FOR HAEMODIALYSIS FOR HAEMODIALYSIS/HAEMOFILTRATION FOR HAEMOFILTRATION FOR FOR IN ADMINISTRATION SYSTEM FOR IN PRE- FOR INJECTION FOR INJECTION IN CARTRIDGE FOR INJECTION IN NEEDLE-FREE INJECTOR FOR INJECTION IN PRE- FILLED PEN FOR INJECTION IN PRE- FOR INJECTION/ FOR INJECTION, LYOPHILISATE FOR, LYOPHILISATE FOR INJECTION/ IN PRE- FOR IONTOPHORESIS FOR ORGAN PRESERVATION FOR PERITONEAL DIALYSIS FOR PROVOCATION TEST FOR SEALANT FOR SKIN-PRICK TEST FOR SKIN-SCRATCH TEST SOLVENT FOR PARENTERAL USE SOLVENT FOR FOR SOLVENT FOR FOR INTRAOCULAR IRRIGATION 17 AND FOR FOR INJECTION IN PRE- FOR BLOOD FRACTION MODIFICATION FOR CARDIOPLEGIA FOR HAEMODIAFILTRATION FOR HAEMODIALYSIS FOR HAEMODIALYSIS/HAEMOFILTRATION FOR HAEMOFILTRATION INTRAVENOUS FOR IN ADMINISTRATION SYSTEM FOR IN PRE- INJECTION FOR INJECTION IN CARTRIDGE FOR INJECTION IN NEEDLE-FREE INJECTOR FOR INJECTION IN PRE- FILLED PEN FOR INJECTION IN PRE- FOR INJECTION/ FOR INJECTION, LYOPHILISATE FOR, LYOPHILISATE FOR INJECTION/ IN PRE- FOR IONTOPHORESIS FOR ORGAN PRESERVATION FOR PERITONEAL DIALYSIS FOR PROVOCATION TEST FOR SEALANT FOR SKIN-PRICK TEST FOR SKIN-SCRATCH TEST SOLVENT FOR PARENTERAL USE SOLVENT FOR FOR SOLVENT FOR FOR INTRAOCULAR IRRIGATION

18 STERILE CONCENTRATE STOMACH IRRIGATION SUBLINGUAL FILM SUBLINGUAL SPRAY, EMULSION SUBLINGUAL SPRAY, SUBLINGUAL SPRAY, SUBLINGUAL TABLET SUPPOSITORY AND EFFERVESCENT GRANULES FOR ORAL AND FOR SPRAY AND SOLVENT FOR FOR INJECTION FOR FOR INJECTION IN CARTRIDGE FOR INJECTION IN PRE- FILLED PEN FOR INJECTION IN PRE- FOR INJECTION, LYOPHILISATE SYRUP TABLET TABLET AND POWDER FOR ORAL TABLET AND SOLVENT FOR RECTAL TABLET FOR RECTAL TABLET FOR ORAL TABLET FOR VAGINAL TOOTHPASTE TRANSDERMAL GEL TRANSDERMAL PATCH TRANSDERMAL TRANSDERMAL SPRAY, TRANSDERMAL PATCH URETHRAL GEL URETHRAL STICK VAGINAL CAPSULE VAGINAL CAPSULE, HARD VAGINAL CAPSULE, SOFT VAGINAL CREAM VAGINAL DELIVERY SYSTEM 18 STERILE CONCENTRATE STOMACH IRRIGATION SUBLINGUAL FILM SUBLINGUAL SPRAY SUBLINGUAL SPRAY SUBLINGUAL SPRAY SUBLINGUAL TABLET SUPPOSITORY AND EFFERVESCENT GRANULES FOR ORAL AND FOR SPRAY AND SOLVENT FOR FOR INJECTION FOR FOR INJECTION IN CARTRIDGE FOR INJECTION IN PRE- FILLED PEN FOR INJECTION IN PRE- FOR INJECTION, LYOPHILISATE SYRUP TABLET TABLET AND POWDER FOR ORAL TABLET AND SOLVENT FOR RECTAL TABLET FOR RECTAL TABLET FOR ORAL TABLET FOR VAGINAL TOOTHPASTE TRANSDERMAL GEL TRANSDERMAL PATCH TRANSDERMAL TRANSDERMAL SPRAY TRANSDERMAL PATCH URETHRAL GEL URETHRAL STICK VAGINAL CAPSULE VAGINAL CAPSULE VAGINAL CAPSULE VAGINAL CREAM VAGINAL DELIVERY SYSTEM

19 VAGINAL EMULSION VAGINAL FOAM VAGINAL GEL VAGINAL OINTMENT VAGINAL VAGINAL VAGINAL TABLET WOUND STICK VAGINAL LIQUID VAGINAL FOAM VAGINAL GEL VAGINAL OINTMENT VAGINAL LIQUID VAGINAL LIQUID VAGINAL TABLET WOUND STICK 1.4 Routes of Administration NAMES AURICULAR BUCCAL CONJUNCTIVAL CUTANEOUS DENTAL ENDOCERVICAL ENDOSINUSIAL ENDOTRACHEAL EPIDURAL EPILESIONAL EXTRA-AMNIOTIC EXTRACORPOREAL GASTRIC GASTROENTERAL GINGIVAL HEMODIALYSIS IMPLANT INFILTRATION INHALATIONAL INTERSTITIAL INTRA-ABDOMINAL INTRA-AMNIOTIC INTRA-ARTERIAL INTRA-ARTICULAR INTRABILIARY INTRABRONCHIAL INTRABURSAL INTRACAMERAL INTRACARDIAC INTRACARTILAGINOUS INTRACAUDAL SHORT TERM OTIC BUCCAL CONJUNC CUTAN DENTAL E-CERVIC E-SINUS E-TRACHE EPIDUR EPILESIONAL X-AMNI X-CORPOR HEMO INFIL INTERSTIT I-ABDOM I-AMNI I-ARTER I-ARTIC I-BILI I-BRONCHI I-BURSAL I-CARDI I-CARTIL I-CAUDAL 19

20 20 INTRACAVERNOUS I-CAVERN INTRACAVITARY I-CAVIT INTRACEREBRAL I-CERE INTRACERVICAL INTRACISTERNAL I-CISTERN INTRACORNEAL I-CORNE INTRACORONARY I-CORONARY INTRACORPUS CAVERNOSUM I-CORPOR INTRADERMAL I-DERMAL INTRADISCAL I-DISCAL INTRADUCTAL I-DUCTAL INTRADUODENAL I-DUOD INTRADURAL I-DURAL INTRA-EPIDERMAL I-EPIDERM INTRA-ESOPHAGEAL I-ESO INTRAHEPATIC INTRALESIONAL I-LESION INTRALYMPHATIC I-LYMPHAT INTRAMEDULLARY I-MEDUL INTRAMENINGEAL I-MENIN INTRAMUSCULAR IM INTRAOCULAR I-OCUL INTRAOSSEOUS INTRAOVARIAN I-OVAR INTRAPERICARDIAL I-PERICARD INTRAPERITONEAL I-PERITON INTRAPLEURAL I-PLEURAL INTRAPROSTATIC I-PROSTAT INTRAPULMONARY I-PULMON INTRASINAL I-SINAL INTRASYNOVIAL I-SYNOV INTRASTERNAL INTRATHECAL IT INTRATUMORAL I-TUMOR INTRAUTERINE I-UTER INTRAVENOUS IV INTRAVENOUS DRIP IV DRIP INTRAVENOUS BOLUS IV BOLUS INTRAVASCULAR I-VASC INTRAVITREAL I-VITRE IN VITRO IONTOPHORESIS ION LARYNGOPHARYNGEAL LARYN NASAL NASAL

21 21 NASOGASTRIC NG OCCLUSIVE DRESSING TECHNIQUE OCCLUS OPHTHALMIC OPHTHALM ORAL ORAL OROMUCOSAL OROPHARYNGEAL ORO OTHER OTHER PARENTERAL PAREN PERIARTICULAR P-ARTIC PERICUTANEOUS PERCUT PERINEURAL P-NEURAL PERIODONTAL P-ODONT PERIOSSEOUS RECTAL RECTAL RETROBULBAR RETRO ROUTE OF ADMINISTRATION NOT APPLICABLE NA SUBCONJUNCTIVAL S-CONJUNC SUBCUTANEOUS SC SUBLINGUAL SL SUBMUCOSAL S-MUCOS TOPICAL TOPIC TRANSDERMAL T-DERMAL TRANSPLACENTAL T-PLACENT URETERAL URETER URETHRAL URETH VAGINAL VAGIN