DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)138. TRETINOIN TOPICALThe following statement shall be included in the package inserts of productscontaining Tretinoin used topically:USE IN PREGNANCY:Studies in animal have shown that oral tretinoin is fetotoxic in rats given500 times the topical human dose and teratogenic in rats given 1,000times the topical human dose. Topical tretinoin has caused delayedossification in a number of bones in the offspring of rats and rabbits given100 to 320 times the topical human dose, respectively. There has beenincreasing incidence of foetal malformation following topical administrationof tretinoi. Use of topical tretinoin is not recommended during pregnancy,especially the first trimester.139. TRIAZOLAMPlease refer to SEDATIVE – HYPNOTIC PRODUCTS140. TRIPROLIDINEThe following statement shall be included on the label and in the packageinserts of liquid oral products containing Triprolidine:WARNINGWhen used for treatment of cough and cold:(a) Not to be used in children less than 2 years of age(b) To be used with caution and doctor‟s/ pharmacist‟s advice inchildren 2 to 6 years of age.Reference: Circular Bil (34) dlm. BPFK/PPP/01/03: Kenyataan Amaran Pada Label danSisip Bungkusan Produk Persediaan Cecair Oral Untuk Rawatan Batuk dan Selsema (Coughand Cold) yang Mengandungi Antihistamin, Antitusif dan Dekongestan (Sebagai Bahan AktifTunggal atau Kombinasi)National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 422
Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)141. VARENICLINEThe following statement shall be included in the package inserts of productscontaining Varenicline:SPECIAL WARNINGS AND PRECAUTIONS FOR USEEffect of smoking cessation:Smoking cessation, with or without pharmacotherapy has been associatedwith the exacerbation of underlying psychiatric illness (eg. depression). Careshould be taken with patients with a history of psychiatric illness and patientsshould be advised accordingly.Depression, rarely including suicidal ideation and suicide attempt, has beenreported in patients undergoing a smoking cessation attempt.UNDESIRABLE EFFECTSPost marketing cases of MI, depression and suicidal ideation have beenreported in patients taking varenicline.Reference: Circular Bil (83) dlm. BPFK/17/FV/28: Maklumat dari European MedicinesAgency (EMEA) berkaitan penggunaan produk Champix (Varenicline) untuk rawatan berhentimerokok (smoking cessation).National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 423
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PART III: NON-CLINICAL DATADrug Reg
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- All information must be provided
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1.2 EXEMPTION FROM PRODUCT REGISTRA
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For product containing Red Yeast Ri
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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