DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)9.2 SPECIFIC LABELLING REQUIREMENTSPlease refer Table 2: List of Substances Which Requires Specific LabellingRequirements and Table 3: Details of Specific Labelling Requirements.Table 2: List of Substances Which Requires Specific Labelling Requirements:NO.SUBSTANCES1. 5-ALPHA REDUCTASE INHIBITOR (5-ARI)2. ACE INHIBITORS3. ACETYLSALICYLIC ACID (ASPIRIN)4. ACTIVATED CHARCOAL/ ATTAPULGITE5. ALBENDAZOLE & BENZIMIDAZOLE ANTIHELMINTICS6. ALFALFA (MEDICO SATIVA)7. ALLOPURINOL8. ALPHA DIHYDROERGOCRYPTINE9. ALPRAZOLAM10. AMIODARONE11. ANTIDEPRESSANTS12. ANTIEPILEPTICS13. ANTIPSYCHOTIC AGENTS14. APOMORPHINE15. ARGININE16. ARIPIPRAZOLE17. ASPARTAME18. BEE POLLEN19. BENZOYL PEROXIDE20. BENZYL ALCOHOL21. BLACK COHOSH (CIMICIFUGAE RACEMOSAE)National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 344
Drug Registration Guidance Document (<strong>DRGD</strong>)NO.SUBSTANCES22. BROMAZEPAM23. BROMOCRIPTINE24. BROMPHENIRAMINE25. CAMPHOR26. CARBAMAZEPINE27. CARBIMAZOLE28. CABERGOLINE29. CEFTRIAXONE30. CETIRIZINE31. CHELIDONIUM MAJUS32. CHITOSAN33. CHLORPHENIRAMINE34. CHORIONIC GONADOTROPHIN35. CLEMASTINE36. CLINDAMYCIN37. CLOBAZAM38. CLOPIDOGREL39. CLOZAPINE40. COLCHICINE41. COX-2 INHIBITORS42. CYPROTERONE ACETATE43. CYTOTOXIC AGENT44. DEXBROMPHENIRAMINE45. DEXTROMETHORPHAN46. DIAZEPAMNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 345
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ATTACHMENT 1Drug Registration Guida
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PART IV: CLINICAL DOCUMENTSDrug Reg
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ATTACHMENT 2Drug Registration Guida
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APPENDIX 5:Drug Registration Guidan
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1. GENERAL INFORMATIONSDrug Registr
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Route of AdministrationTAMC(CFU/g o
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d) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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