EMA Rejection For Raxone Plunges UK Early Access Scheme Into Uncharted Territory
Santhera can carry on making Raxone available to patients with Duchenne muscular dystrophy in the UK under the early access to medicines scheme while the MHRA works out what to do now that the European Medicines Agency has turned the product down. In the US, meanwhile, the company has received the green light to provide the drug to DMD patients at no cost under a similar scheme.
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This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.
New medicines under evaluation at the European Medicines Agency.
The European Medicine Agency has recommended extending the therapeutic indication of a raft of drugs that are already authorized in the EU.