DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)106. PHENIRAMINEThe following statement shall be included on the label and in the packageinserts of liquid oral products containing Pheniramine: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)107. PHENYLEPHRINEThe following statement shall be included on the labels and in the packageinsert of liquid oral products containing Phenylephrine: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)108. PIRIBEDILPlease refer to DOPAMINERGIC INGREDIENTNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 402
Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)109. PIROXICAMThe following additional information shall be included in the package inserts ofproducts containing Piroxicam:WARNING AND PRECAUTIONTreatment should always be initiated by a physician experienced inthe treatment of rheumatic diseases.Use the lowest dose (no more than 20mg per day) and for theshortest duration possible. Treatment should be reviewed after 14days.Always consider prescribing a gastro-protective agent.CONTRAINDICATIONPiroxicam should not be prescribed to patient who is more likely todevelop side effects, such as those with a history of gastro-intestinaldisorders associated with bleeding, or those who have had skinreactions to other medicines.Piroxicam should not be prescribed in association with any otherNSAID or an anticoagulant.Reference: Circular Bil (80) dlm BPFK/02/5/1.3: Menghadkan Indikasi bagi Produk untukKegunaan Systemic yang Mengandungi Piroxicam kepada 'For the symptomatic relief of painand inflammation in patients with osteoarthritis, rheumatoid arthritis and ankylosing spondylitis'dan Tambahan Amaran dan Kontraindikasi terkini pada sisip bungkusan110. PRAMIPEXOLEPlease refer to DOPAMINERGIC INGREDIENTNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 403
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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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Route of AdministrationTAMC(CFU/g o
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e) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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