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26-10-2011: 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.
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European Commission authorizes EU-wide marketing and distribution of Biofrontera's Ameluz
Biofrontera was informed by the European Commission that its product Ameluz® (in development called BF-200 ALA) was approved for distribution throughout the entire EU, Norway, Island and Liechtenstein. Already in October had the responsible "European Medicines Agency" recommended the approv ... more
The EMA recommends approval of Biofrontera's BF-200 ALA
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 ... more
Positive review of the European Medicines Agency in the approval process of Biofrontera's BF-200 ALA
Biofrontera has received a positive interim report of the responsible committee of the European Medicines Agency (EMA) in the ongoing centralized approval process of BF-200 ALA for the treatment of actinic keratosis.The "Committee for Medicinal Products for Human Use (CHMP)" provides applic ... more
The European Medicines Agency (EMA) has been ordered by the General Court of the European Union not to provide documents as part of two access-to-documents requests until a final ruling is given by the Court. These interim rulings were made as part of court cases brought by two pharmaceutic ... more
Recommendation to suspend tetrazepam-containing medicines endorsed by CMDh
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European Medicines Agency publishes 2012 annual report
The European Medicines Agency has published its 2012 annual report. The report highlights the main trends recently observed in the Agency’s activities. For the past few years, the Agency has received a stable number of initial marketing authorisation applications (MAAs) for human medicines, ... more
European Medicines Agency (EMA)
The European Medicines Agency is a decentralised agency of the European Union, located in London. The Agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union. more
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