NeLM news service
European CHMP recommends refusal of marketing authorisation for skeletal muscle relaxant tolperison (Myderison®)

Source: EMEA

Date published: 23/10/2009 16:05

Summary
by: Yuet Wan

Following a referral by Member States for a review of skeletal muscle relaxant tolperison (Myderison®), the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has concluded that its benefit/risk ratio is not considered to be favourable and therefore it recommends the refusal of the marketing authorisation in the Concerned Member States and the revocation of the marketing authorisation in the Member States where the product is currently authorised. Further information is available from a Q&A at the link below.

Q&A

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