Press Release: Recommendation to suspend tetrazepam-containing medicines endorsed by CMDh

Author (Corporate)
Series Title
Series Details EMA/256383/2013 (29.04.13)
Publication Date 29/04/2013
Content Type

The European Medicines Agency (EMA), on 29 April 2013, announced that marketing authorisations of tetrazepam-containing medicines would henceforth be suspended across the European Union.

Tetrazepam, a medicine of the benzodiazepine class, is used in several EU Member States to treat painful contractures (such as in low back pain and neck pain) and spasticity (excessive stiffness of muscles).

The review of tetrazepam was triggered by the French National Agency for the Safety of Medicine and Health Products (ANSM), following reports of serious skin reactions with this medicine in France.

Source Link Link to Main Source http://www.emea.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2013/04/news_detail_001777.jsp&mid=WC0b01ac058004d5c1
Related Links
EMA: Press Release: EMA/256383/2013 (29.04.13): Recommendation to suspend tetrazepam-containing medicines endorsed by CMDh http://www.emea.europa.eu/docs/en_GB/document_library/Press_release/2013/04/WC500142552.pdf

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