DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)based on well documented information as an aid to the industry to complywith the labelling requirement for products used during pregnancy.Table 10: List of Prohibited Ingredients in PregnancyLatin Compendium NameCommon/ ChineseNameA Acorus Calamus CalamusRemarksAchillea MillefoliumAngelica ArchangelicaYarrowAngelicaAngelica sinensis Dong Quai When taken orallyArtemisia VulgarisArctostaphylos Uva UrsiArtemisia AbsinthiumAstragalus gummiferMugwortUva UrsiWormwoodTragacanthB Bryonia Alba White BryonyBupleurum chinense,Bupleurum falcatumBupleurumC Calendula Officinalis CalendulaCapsella Bursa-PastorisCassia MarilandicaShepherd‟s PurseSennaCaulophyllum Thalictroides Blue Cohosh When taken orallyChamaemelum nobile(Anthemis nobilis)ChenopodiumAmbrosioidesCichorium intybusRoman ChamomileEpazoteChicoryWhen taken orallyCimicifuga Racemosa Black Cohosh When taken orallyCnicus BenedictusConium maculatumConvalaria MajalisCortex CinnamomiBlessed ThistleHemlockLily of the ValleyRou GuiNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 290
Drug Registration Guidance Document (<strong>DRGD</strong>)Latin Compendium NameCortex MoutanCrocus SativusCommon/ ChineseNameMu Dan PiSaffronRemarksE Equisetum arvense L. HorsetailF Flos Carthami Hong HuaFlos GenkwaFolium SennaeFructus AurantiiFructus Aurantii ImmaturusYuan HuaFan Xie YeZhi KeZhi ShiG Gentiana lutea GentianGinkgo BilobaGinkgoH Helleborus spp. HelleboreI Iris Versicolor Blue FlagIpecac IpecachuanaIpecacJ Juglans Canadensis ButternutJuglans nigraJuniper (Juniperuscommunis)Black WalnutJuniper BerriesL Leonurus Cardiaca MotherwortM Marrubium Vulgare HorehoundMentha PulegiumPennyroyalMonarda didymaBee BalmWhen used orallyor topicallyMylabris / Radix SacchariArundinaceiBan MaoN Natrii Sulfas Mang XiaoNepeta catariaCatnipO Oenothera biennis L. Evening PrimrosePPanax Ginseng, PanaxQuinquefoliusGinsengPassiflora incarnata L. Passion Flower When taken orallyNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 291
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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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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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