
Miglustat capsules
Form: Capsules
Strength: 100 mg
Reference Brands: Zavesca(US)
Category: Orphan Drugs
Miglustat capsules, marketed as Zavesca, are approved in the US by the FDA and in the EU via EMA for treating Gaucher’s disease type 1 and Niemann-Pick disease type C. Regulatory approval requires a detailed dossier including clinical efficacy, safety profiles, manufacturing standards, and pharmacovigilance plans. In the US, the FDA reviews comprehensive clinical trial and quality data for timely approval, while the EMA ensures compliance with regional safety, efficacy, and manufacturing regulations. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper regional adherence supports swift approval, safe use, and worldwide availability, aiding in management of rare metabolic disorders.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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