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Regulatory approval in Europe granted for glatiramer acetate 40mg/ml

Synthon has announced that it has successfully concluded the decentralised procedures for glatiramer acetate 40mg/ml pre-filled syringe for the treatment of relapsing forms of multiple sclerosis and received regulatory approval in Europe.

Synthon received regulatory clearance in all 27 EU/EEA member states involved in the procedures. Granting of national marketing authorizations will follow in the near future.

Synthon’s 20mg/ml glatiramer acetate product has already received marketing authorisations in these European countries. As of the end of 2016, Synthon’s partners have introduced glatiramer acetate 20mg/ml in the majority of these countries.

We are very pleased with this approval,” commented Synthon’s chief executive officer Jacques Lemmens. “It allows us to make an affordable version of the 40mg/ml dosage strength of glatiramer acetate available to MS patients in Europe.”