DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)46. DIAZEPAMPlease refer to SEDATIVE – HYPNOTIC PRODUCTS47. DICLOFENAC SODIUMThe following statement shall be included in the package inserts of productscontaining Diclofenac sodium:PRECAUTIONSevere cutaneous reactions, including Stevens - Johnson syndrome and toxicepidermal necrolysis (Lyell‟s syndrome), have been reported with diclofenacsodium. Patients treated with diclofenac sodium should be closely monitoredfor signs of hypersensitivity reactions. Discontinue diclofenac sodiumimmediately if rash occurs.Adverse effects: Dermatological: Occasional - rashes or skin eruptions Casesof hair loss, bullous eruptions, erythema multiforme, Stevens- Johnsonsyndrome, toxic epidermal necrolysis (Lyell‟s syndrome), and photosensitivityreactions have been reported.48. DICYCLOMINEThe following boxed warning shall be included on the labels and in thepackage inserts of products containing Dicyclomine:WARNINGDicyclomine is not recommended for use in infantsunder the age of six monthNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 378
Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)49. DIPHENHYDRAMINEThe following statement shall be included on the labels and in the packageinserts of products containing Diphenhydramine: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 in children2 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 | 379
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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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