Biofrontera AG:Ad hoc: The EMA recommends approval of Biofrontera's BF-200 ALA
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Biofrontera AG /
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Ad hoc: The EMA recommends approval of Biofrontera's BF-200 ALA
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Leverkusen, Germany, October 21, 2011 - The European Medicines Agency (EMA)
issued a favourable opinion on Biofrontera's marketing approval application for
its new medicinal product BF-200 ALA for the treatment of actinic keratosis.
There was no recommendation for a restriction or temporal limitation of the
approval. The product will be marketed under the name Ameluz(®). The positive
assessment report on the product, generated by the responsible committee within
the EMA, the Committee for Medicinal Products for Human Use (CHMP), will now be
forwarded to the European Commission for the formal conclusion of the process.
Before the marketing approval will be issued, anticipated in December, the
product information will be translated into all languages of the European Union
and attuned with the respective local health agencies. Following approval,
Ameluz(®) can be commercialized in all 27 countries of the EU as well as Norway,
Island and Liechtenstein.
Biofrontera AG, Hemmelrather Weg 201, 51377 Leverkusen, Germany
ISIN: DE0006046113, WKN: 604611
Contact:
Werner Pehlemann
Biofrontera AG
Tel.: +49 (0214) 87 63 20
Fax.: +49 (0214) 87 63 290
E-mail:w.pehlemann(at)biofrontera.com
--- End of Message ---
Biofrontera AG
Hemmelrather Weg 201 Leverkusen Germany
WKN: 604611;ISIN: DE0006046113;
Listed: Freiverkehr in Börse Stuttgart,
Freiverkehr in Börse Berlin,
Open Market (Freiverkehr) in Frankfurter Wertpapierbörse,
Freiverkehr in Bayerische Börse München,
Regulierter Markt in Börse Düsseldorf;
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Source: Biofrontera AG via Thomson Reuters ONE
[HUG#1556966]
Unternehmensinformation / Kurzprofil:
Datum: 21.10.2011 - 14:53 Uhr
Sprache: Deutsch
News-ID 78926
Anzahl Zeichen: 2517
contact information:
Town:
Leverkusen
Kategorie:
Business News
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