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The European Medicines Agency said Friday that on April 19 it completed an arbitration procedure following a disagreement among European Union member states regarding the authorization of the medicine Yvidually, a combined contraceptive pill, and associated names.
The Agency's Committee for Medicinal Products for Human Use, or CHMP, concluded that the benefits of Yvidually outweigh its risks, and the marketing authorization can be granted in all EU member states as well as Iceland and Norway, the agency said in a statement.
Bayer B.V., the Dutch unit of Bayer AG (BAYN.XE, BAYRY) submitted Yvidually to the Netherlands medicines regulatory agency for a decentralized procedure. This is a procedure where one member state assesses a medicine with a view to granting a marketing authorization that will be valid in this country as well as in other member states.
The grounds for the referral were concerns by France about the effectiveness of the proposed extended use of the medicine and the irregular bleeding episodes that might occur during the days of intake of the pill, the agency said. France was also concerned that the tablet dispenser hadn't been used in the main clinical studies.
-By Frankfurt Newsroom, Dow Jones Newswires; +49 69 29725 500