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Published on 5 October 2017

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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 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.”



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