Press Release: European Medicines Agency gives first positive opinion for paediatric-use marketing authorisation

Author (Corporate)
Series Title
Series Details EMA/CHMP/495827/2011 (24.6.11)
Publication Date 24/06/2011
Content Type

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), in June 2011, gave its first positive opinion for a paediatric-use marketing authorisation (PUMA) for Buccolam (midazolam), from ViroPharma SPRL, intended for the treatment of prolonged, acute, convulsive seizures in paediatric patients from the age of 3 months to 18 years.

Source Link http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2011/06/news_detail_001287.jsp&mid=WC0b01ac058004d5c1&murl=menus/news_and_events/news_and_events.jsp&jsenabled=true
Related Links
EMA: Press Release: EMA/CHMP/495827/2011 (24.6.11) http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2011/06/WC500107995.pdf

Subject Categories ,
Countries / Regions