Pomalidomide Teva (pomalidomide)
- Region
- 🇪🇺 EU
- Active substance
- pomalidomide
- Company
- Teva GmbH
- Status
- Authorised
- Therapeutic area
- Multiple Myeloma
- CHMP opinion
- Thu 19 Sep 2024
- EU approval
- Thu 14 Nov 2024
- Designations
- Generic, Additional monitoring
- Application
- EMEA/H/C/006302
- ATC
- L04AX06
- Official record
- www.ema.europa.eu
Indication
Pomalidomide Teva in combination with bortezomib and dexamethasone is indicated in the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide. Pomalidomide Teva 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 Krka Authorised · KRKA tovarna zdravil d.d. Novo mesto
- 🇪🇺 Pomalidomide Accord Authorised · Accord Healthcare S.L.U.
- 🇪🇺 Pomalidomide Zentiva Authorised · Zentiva k.s.
- 🇪🇺 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.