MediGene AG Receives Marketing Authorization for Veregen in Germany
MediGene AG announced that it has received German marketing authorization for Veregen® for the treatment of genital warts from the Federal Institute for Drugs and medical devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM).
The marketing authorization application for Veregen® (formerly Polyphenon E® Ointment) was assessed positively in a decentralized approval procedure by the German, Austrian, and Spanish national regulatory authorities. The formal issue of marketing authorization in Germany is the first implementation of the assessment by a national regulatory authority. Marketing authorization of Veregen® in Germany, the reference member state in this decentralized procedure, will now provide a basis for additional marketing authorization applications to be submitted in additional European countries. The issuance of formal marketing authorizations in Austria and Spain are expected within the next few months.
MediGene intends to distribute Veregen® in Germany and other European countries via marketing partners. In the USA Veregen® is already available, and is distributed by MediGene's licensee Nycomed US Inc. In addition, MediGene recently announced the conclusion of a partnership with the Spanish company Juste S.A.Q.F. for the distribution of Veregen® in Spain and Portugal.
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