DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)2. For relief of flatulence, stomach ache, mild diarrhoea, and loss ofappetite/ untuk melegakan kembung perut, sakit perut, cirit-birit ringandan kurang selera makan.3. For relief of mild diarrhoea, vomiting and improve appetite/ untukmelegakan cirit-birit, muntah ringan dan menambah selera makan.4. For relief of mild constipation/ untuk melegakan sembelit ringan.5. To improve appetite and digestion/ untuk menambah selera makandan pencernaan.6. For relieving abdominal pain and flatulence/ untuk melegakan sakitperut dan kembung perut.7. For relief of stomach ache, constipation, mild vomiting and indigestion/untuk melegakan sakit perut, sembelit, muntah ringan dan makanantidak hadzam.8. Aid in digestion/ untuk membantu penghadzaman.g) Women‟s Health/ Kesihatan Wanita“Traditionally used…../ “Digunakan secara tradisional….1. To relieve menstrual pain, headache and to regulate menstruation/untuk melegakan senggugut, sakit kepala dan melancarkan perjalananhaid.2. To reduce body weight/ untuk mengurangkan berat badan.3. For relief of vaginal discharge/ untuk melegakan keputihan.4. For women after childbirth/ untuk wanita lepas bersalin.5. For general wellbeing and strengthen the body after childbirth/ untukkesihatan dan menguatkan badan wanita selepas bersalin.6. For women after childbirth to reduce body weight/ untuk ibu-ibuselepas bersalin untuk mengurangkan berat badan.7. For symptomatic relief of vaginal discharge and mild itch/ untukmelegakan keputihan dan gatal-gatal ringan.8. To improve menstrual flow, for relief of menstrual pain, vaginaldischarge and flatulence/ untuk melancarkan haid, melegakansenggugut, keputihan dan kenbung perut.9. For strengthening body muscle and reducing body weight/ untukmengencangkan otot-otot tubuh dan mengurangkan berat badan.10. For general health of women after childbirth/ untuk menyihatkan rahimselepas melahirkan anak.11. To relieve symptoms of menopause/ untuk melegakan simptommenopause. [Note: For specific active ingredient only, examples: redclover (trifolium pratense) and black cohosh (cimicifuga racemosa)]National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 266
Drug Registration Guidance Document (<strong>DRGD</strong>)h) Men‟s Health/ Kesihatan Lelaki“Traditonally used…./ “Digunakan secara tradisional….1. For energy and men‟s health/ for vitality/ untuk memulihkan tenaga dankesihatan lelaki.i) Skin And External Usage/ Kulit Dan Kegunaan Luar“Traditionally used…../ “Digunakan secara tradisional…1. For symptomatic relief of pain and itch associated with insect bites/untuk melegakan sakit dan gatal-gatal digigit serangga.2. For relief of minor burns/ untuk melegakan melecur ringan.3. For relief minor cuts/ untuk melegakan luka-luka ringan.4. For relief of minor bruises/ untuk melegakan lebam yang ringan.5. For reducing pimples/ untuk mengurangkan jerawat.6. To help maintaining healthy skin, nail and hair/ untuk kesihatan kulit,kuku dan rambut.7. For reducing pimples and mild itch/ untuk melegakan jerawat dangatal-gatal ringan.2.3.2 NON-PERMISSIBLE INDICATIONSTable 6:NO.NON-PERMISSIBLE INDICATIONS1. Penyakit atau kecacatan ginjal / Disease or defects of the kidney2. Penyakit atau kecacatan jantung / Disease or defects of the heart3. Kencing manis / Diabetes4. Epilepsi atau sawan / Epilepsy or fits5. Kelumpuhan / ParalysisNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 267
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Page 220 and 221: ATTACHMENT 1Drug Registration Guida
Page 228 and 229: PART IV: CLINICAL DOCUMENTSDrug Reg
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Page 238 and 239: 1. GENERAL INFORMATIONSDrug Registr
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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