Saturday, March 23, 2013 11:33 AM
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Tony Miles
The Committee for Medicinal Products for Human Use (CHMP) issued positive opinions on two new MS therapies. Recommending the granting of a marketing authorisation for the medicinal product Tecfidera 120 mg and 240 mg, gastro-resistant hard capsules, intended for the treatment of adult patients with relapsing remitting multiple sclerosis and Aubagio 14 mg film-coated tablet intended for the treatment of multiple sclerosis.
The Committee also concluded that the active substance contained in Aubagio, teriflunomide, could not be considered to be a new active substance. It is expected that Sanofi-aventis will appeal against this conclusion.
The full Summaries Of Opinion can be read here: Tecfidera , Aubagio
Source: The Committee for Medicinal Products for Human Use (CHMP) (22/03/13)
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