DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)7. ALLOPURINOLThe following statement shall be included in the package inserts of productscontaining Allopurinol:WARNINGAllopurinol should be discontinued at the first appearance of skin rash or othersigns which may indicate an allergic reaction. Hypersensitivity to allopurinolusually appears after some weeks of therapy, and more rarely immediatelyafter beginning treatment.In some instances, a skin rash may be followed by more severe reactions suchas exfoliative, urticarial and purpuric lesion as well as Stevens-Johnsonsyndrome, and/or generalized vasculitis, irreversible hepatotoxicity and evendeath.8. ALPHA DIHYDROERGOCRYPTINEPlease refer to DOPAMINERGIC INGREDIENT9. ALPRAZOLAMPlease refer to SEDATIVE – HYPNOTIC PRODUCTS10. AMIODARONEThe following boxed warning shall be included on the package inserts ofproducts containing Amiodarone:National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 360
Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)11. ANTIDEPRESSANTSThe following statement shall be included in the package inserts of productsused as antidepressants:WARNINGSuicidality in Children and AdolescentsAntidepressants increase the risk of suicidal thinking and behavior(suicidality) in children and adolescents with major depressive disorder(MDD) and other psychiatric disorders.Anyone considering the use of an antidepressant in a child or adolescentfor any clinical use must balance the risk of increased suicidality with theclinical need.Patients who are started on therapy should be observed closely for clinicalworsening, suicidality, or unusual changes in behavior.Families and caregivers should be advised to closely observe the patientand to communicate with the prescriber.The indication(s) approved in paediatric for the particular drug should beclearly stated / included.Reference: Circular Bil(41)dlm BPFK/02/5/1.3: Keputusan Pihak Berkuasa Kawalan Dadah(PBKD) Berhubung Tambahan Amaran Berkaitan Dengan 'Suicidality In Children AndAdolescents Treated With Antidepressants'12. ANTIEPILEPTICSThe following statement shall be included in the package inserts of productsused as antiepileptics:WARNING AND PRECAUTIONPotential for an increase in risk of suicidal thoughts or behaviors.Reference: Circular Bil (43) dlm. BPFK/PPP/01/03: Kenyataan Amaran Berkaitan Dengan“Potential for an Increase in Risk of Suicidal Thoughts or Behaviours” yang Perlu DimuatkanPada Sisip Bungkusan Produk AntiepileptikNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 361
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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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