European Medicines Agency: Approvals January 2021

The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) recommended 13 new medications for approval and three therapeutic indication extensions in its January 2021 meeting.

Source: EMA

Highlights

conditional marketing authorisation for COVID-19 Vaccine AstraZeneca (COVID-19 Vaccine (ChAdOx1-S [recombinant]))

Seffalair Spiromax (salmeterol / fluticasone) and its duplicate BroPair Spiromax (salmeterol / fluticasone) received a positive opinion for the treatment of asthma

marketing authorisation for Byfavo (remimazolam) for procedural sedation.

conditional marketing authorisation for Nexpovio* (selinexor) for the treatment of relapsed and refractory multiple myeloma.

Two biosimilar medicines, Alymsys (bevacizumab) and Oyavas (bevacizumab), received a positive opinion for the treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.

Read the details of January 2021 decisions at EMA

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