VIVUS receives positive recommendation from CHMP supporting Avanafil approval
in EUVIVUS announced that the European Medicines Agency's, or EMA,
Committee for Medicinal Products for Human Use, or CHMP, adopted a positive
opinion recommending the granting of a marketing authorization for avanafil for
the treatment of erectile dysfunction in the European Union. The CHMP
recommendation will now be referred to the European Commission, which grants
marketing authorization for medicines in the European Union. A final decision
from the EC regarding the SPEDRA Marketing Authorization Application is expected
within approximately two months.
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