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Home>Regulatory Approval in Europe granted for Synthon’s glatiramer acetate 40 mg/ml

Regulatory Approval in Europe granted for Synthon’s glatiramer acetate 40 mg/ml

Regulatory Approval in Europe granted for Synthon’s glatiramer acetate 40 mg/ml

10/05/2017

Regulatory Approval in Europe granted for Synthon’s glatiramer acetate 40 mg/ml

Synthon today announced that it has successfully concluded the decentralized procedures for glatiramer acetate 40 mg/ml pre-filled syringe for the treatment of relapsing forms of multiple sclerosis and received regulatory approval in Europe. Synthon’s three-times-a-week glatiramer acetate is a therapeutically equivalent version of the originator medicine Copaxone ®* 40mg.

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 20 mg/ml glatiramer acetate product has already received marketing authorizations in these European countries. As of the end of 2016, Synthon's partners have introduced glatiramer acetate 20 mg/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 40 mg/ml dosage strength of glatiramer acetate available to MS patients in Europe.”

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About Synthon

Synthon, with headquarters in Nijmegen, the Netherlands, is an international pharmaceutical company and a leader in the field of generic medicines. The company started its biopharmaceutical franchise in 2007 and is building a promising portfolio of next generation medicines. Synthon is developing rapidly into a specialty pharmaceutical company, focusing on the therapeutic areas of oncology and auto-immune diseases. Synthon products are currently approved by regulatory agencies in over 90 countries worldwide and marketed through strategic partnerships and – in dedicated areas – through direct sales. Synthon employs about 1,900 staff worldwide, and in 2016 it recorded a turnover of EUR 258 million. For more information, go to www.synthon.com.

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