Pomalidomide Zentiva (pomalidomide)
- Region
- 🇪🇺 EU
- Active substance
- pomalidomide
- Company
- Zentiva k.s.
- Status
- Authorised
- Therapeutic area
- Multiple Myeloma
- CHMP opinion
- Thu 30 May 2024
- EU approval
- Wed 24 Jul 2024
- Designations
- Generic
- Application
- EMEA/H/C/006294
- ATC
- L04AX06
- Official record
- www.ema.europa.eu
Indication
Treatment of adults with multiple myeloma who have received at least one prior treatment regimen including lenalidomide. Pomalidomide Zentiva in combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Pomalidomide Teva Authorised · Teva GmbH
- 🇪🇺 Pomalidomide Krka Authorised · KRKA tovarna zdravil d.d. Novo mesto
- 🇪🇺 Pomalidomide Accord Authorised · Accord Healthcare S.L.U.
- 🇪🇺 Pomalidomide Viatris Authorised · Viatris Limited
- 🇪🇺 Imnovid (previously Pomalidomide Celgene) Authorised · Bristol-Myers Squibb Pharma EEIG
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.