Thalidomide Lipomed (thalidomide)
- Region
- 🇪🇺 EU
- Active substance
- thalidomide
- Company
- Lipomed GmbH
- Status
- Authorised
- Therapeutic area
- Multiple Myeloma
- CHMP opinion
- Thu 21 Jul 2022
- EU approval
- Mon 19 Sep 2022
- Application
- EMEA/H/C/005715
- ATC
- L04AX02
- Official record
- www.ema.europa.eu
Indication
Thalidomide Lipomed in combination with melphalan and prednisone is indicated as first line treatment of patients with untreated multiple myeloma, aged ? 65 years or ineligible for high dose chemotherapy. Thalidomide Lipomed is prescribed and dispensed in accordance with the Thalidomide Lipomed Pregnancy Prevention Programme (see section 4.4).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Thalidomide BMS (previously Thalidomide 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.