DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)2. ARGININEThe following statement shall be included on the labels and in the packageinsert of oral preparations containing Arginine for health supplements:WARNING:Arginine is not recommended for patients following a heart attack.3. ASPARTAMEThe following statement shall be included on the labels and in the packageinsert of products containing Aspartame:WARNING:Unsuitable for phenylketonurics4. BEE POLLENThe following statement shall be included on the labels and in the packageinsert of product containing bee pollen:This product contains Bee Pollen and may cause severe allergicreactions, including fatal anaphylactic reactions in susceptible individuals.Asthma and allergy sufferers may be at greater risks.5. CHITOSANThe following statement shall be included on the labels and in the packageinsert of products containing chitosan.“DERIVED FROM SEAFOOD”6. GINKGO BILOBA/ GINKGO EXTRACTThe following statements shall be included on the labels and in the packageinsert of products containing Ginkgo Biloba/ Ginkgo Extract:National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 212
Drug Registration Guidance Document (<strong>DRGD</strong>)As the use of Ginkgo may increase the tendency of bleeding, please consultyour physician/ pharmacist if you are on or intend to start using any othermedicines and before you undergo any surgical/ dental procedure.(Memandangkan Ginkgo boleh meningkatkan kemungkinan pendarahan, silarujuk kepada doktor/ ahli farmasi sekiranya anda sedang atau/ akanmenggunakan ubat lain dan sebelum prosedur pembedahan/ dentaldijalankan).7. GINSENGThe following statements shall be included on the labels and in the packageinsert of products containing Ginseng (including all Panax genus):Contraindicated in pregnant women.Safe use in lactating women and children has not been established.Do not exceed the stated dose.Safety on long term use has not been established.8. INGREDIENTS DERIVED FROM SEAFOODThe following statement shall be included on the labels and in the packageinsert of products.“DERIVED FROM SEAFOOD”9. ROYAL JELLYThis product contains royal jelly and may cause severe allergic reactionsincluding fatal anaphylactic reactions in susceptible individuals.Asthma and allergy sufferers may be at the greater risk.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 213
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Page 230 and 231: PART III: NON-CLINICAL DATADrug Reg
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For product containing Red Yeast Ri
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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