Human medicines European public assessment report (EPAR): Pomalidomide Viatris, pomalidomide, Status: Opinion

Pomalidomide Viatris will be available as 1 mg, 2 mg, 3 mg and 4 mg hard capsules.

Metadata
Provider: 
European Medicines AgencyEuropean Medicines Agency
URL: 
https://www.ema.europa.eu/en/medicines/human/EPAR/pomalidomide-viatrishttps://www.ema.europa.eu/en/medicines/human/EPAR/pomalidomide-viatris
Retrieved on: 
Tuesday, January 2, 2024
Information
Tags: 
Medical Subject Headings, Marketing, European Commission, INN, Physician, ATC, EMA, International, Multiple myeloma, Civil service commission, Lenalidomide, Dexamethasone, Bortezomib, Medication package insert, Committee, Patient, Anatomy, Medicine, CHMP, Generic drug
Geotags: 
EUROPEAN UNION, EU
Summary
Key Points: 
  • Pomalidomide Viatris will be available as 1 mg, 2 mg, 3 mg and 4 mg hard capsules.
  • Pomalidomide Viatris is a generic of Imnovid, which has been authorised in the EU since 05 August 2013.
  • Studies have demonstrated the satisfactory quality of Pomalidomide Viatris and its bioequivalence to the reference product Imnovid.
  • Treatment with Pomalidomide Viatris should be carried out under the supervision of physicians experienced in the treatment of multiple myeloma.
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