BfArM - Federal Institute for Drugs and Medical Devices

Navigation and service

Information Letter on Separation of the combined indications for methotrexate medac 25 mg/ml solution for injection (in vials)

Active substance: Methotrexate

The product Methotrexat medac 25 mg/ml solution for injection (in vials) with the marketing authorisation number 80379.00.00 is only available for oncological indications. The marketing authorisations of all other methotrexate-containing products of the marketing authorisation holder with either autoimmune indication(s) or oncological indications are unaffected.

Download DHPC / Information letter , Download_VeroeffentlichtAm_EN PDF, 132KB, File is accessible