DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)d) Pain & Fever/ Sakit Am & Demam“Traditionally used…./ “Digunakan secara tradisional….1. To relieve/ alleviate pain/ untuk melegakan kesakitan.2. For relieving fever/ untuk melegakan demam.3. For relieving headache/ untuk melegakan sakit kepala.4. For relieving pain and itchiness related to piles/ untuk melegakankesakitan dan rasa gatal akibat buasir.5. For symptomatic relief of body heatiness/ body heat / untuk melegakanpanas badan.e) Cough & Cold/ Batuk & Selsema“Traditionally used……/ “Digunakan secara tradisional…..1. For relief of fever, cough and cold/ untuk melegakan demam, batukdan selsema.2. For relief of sore throat/ untuk melegakan sakit tekak.3. For reducing phlegm and relief of cough, sore throat and bodyheatiness/ untuk mengurangkan kahak dan melegakan batuk, sakittekak dan panas badan.4. For relief of throat irritations and cough/ untuk melegakan sakit tekakdan batuk.5. For relief of nasal congestion/ untuk melegakan hidung tersumbat.6. For relief of sore throat and cough/ untuk melegakan sakit tekak danbatuk.7. For relief of mouth ulcers due to heatiness/ untuk melegakan sakitmulut akibat panas badan.8. To relieve sinusitis/ untuk melegakan resdung.f) Digestive System/ Sistem Pencernaan“Traditionally used…./ “Digunakan secara tradisional….1. For relief of stomach ache, mild diarrhoea/ untuk melegakan sakitperut, cirit-birit ringan.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 268
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 | 269
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Page 230 and 231: PART III: NON-CLINICAL DATADrug Reg
Page 232 and 233: - All information must be provided
Page 242 and 243: 1.2 EXEMPTION FROM PRODUCT REGISTRA
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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