Pomalidomide Capsules
Form: capsules.
Strength: 2 mg, 4 mg, 3 mg, and 4 mg
Reference Brands: Talquetamide(US), Pomalyst(EU)
Category: Orphan Drugs
Pomalidomide capsules, marketed as Pomalyst, are approved in the US by the FDA and in the EU via EMA for relapsed and refractory multiple myeloma. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. The FDA reviews clinical trial and quality data to ensure safety and effectiveness, while the EMA evaluates compliance with regional safety and manufacturing standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper adherence to regional requirements supports timely approval, safe use, and widespread availability, helping improve long-term outcomes for multiple myeloma patients worldwide.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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