European Medicines Agency Completes Arbitration Over Bayer Product
April 20 2012 - 1:46PM
Dow Jones News
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
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