EMA: NicOx S.A. Withdraws Its Marketing Authorisation Application for Beprana
The decision to withdraw the application was based on the fact that the CHMP considers that the data provided do not allow the it to conclude on a positive benefit-risk balance.
The European Medicines Agency has been formally notified by NicOx S.A. of its decision to withdraw its application for a centralised marketing authorisation for Beprana (naproxcinod), 375 mg hard capsules, used for the relief of the signs and symptoms of osteoarthritis of the knee and hip in adults.
The application for the marketing authorisation for Beprana was initially submitted to the Agency on 21 December 2009. At the time of the withdrawal it was under review by the Agency’s Committee for Medicinal Products for Human Use (CHMP).
In its official letter, the company stated that their decision to withdraw the application was based on the fact that the CHMP considers that the data provided do not allo
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