🇪🇺 Thalidomide (100mg) in European Union

EMA authorised Thalidomide (100mg) on 16 April 2008

Marketing authorisations

Application: EMEA/H/C/000823
Marketing authorisation holder: Bristol-Myers Squibb Pharma EEIG
Local brand name: Thalidomide BMS (previously Thalidomide Celgene)
Indication: Thalidomide BMS in combination with melphalan and prednisone as first line treatment of patients with untreated multiple myeloma, aged >/= 65 years or ineligible for high dose chemotherapy. Thalidomide BMS is prescribed and dispensed according to the Thalidomide Celgene Pregnancy Prevention Programme (see section 4.4).
Status: approved

Application: EMEA/H/C/005715
Marketing authorisation holder: Lipomed GmbH
Local brand name: Thalidomide Lipomed
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).
Status: approved

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Is Thalidomide (100mg) approved in European Union?

Yes. EMA authorised it on 16 April 2008; EMA authorised it on 19 September 2022.

Who is the marketing authorisation holder for Thalidomide (100mg) in European Union?

Bristol-Myers Squibb Pharma EEIG holds the EU marketing authorisation.