September batch of EMA/CHMP recommendations
The European Medicines Agency ’s human medicines committee (CHMP) recommended five novel medicines and two biosimilars for approval at its September 2021 meeting.
The CHMP’s positive opinion will now be referred to the European Commission (EC), which grants marketing authorizations for medicines in Europe, a process that usually take two to three months.
The Committee adopted a positive opinion for Artesunate Amivas (artesunate), from Amivas Ireland, for the initial treatment of severe malaria in adults and children. This medicine has an orphan designation because malaria has a low prevalence in the European Union.
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