Press Release: European Medicines Agency recommends suspension of marketing authorisations for meprobamate-containing medicines in the European Union

The European Medicines Agency (EMA), in January 2012, recommended the suspension of all marketing authorisations for meprobamate-containing medicines for oral use in the European Union, because their risks, particularly the risk of serious side effects affecting the nervous system, are greater than their benefits. To ensure prescribers have enough time to determine the most appropriate treatments for individual patients, the Committee for Medicinal Products for Human Use (CHMP) recommended that the withdrawal of the medicines from the market be carried out gradually, within 15 months of the European Commission decision.

Meprobamate is a sedative medicine used to treat the symptoms of anxiety and related conditions, including anxiety states, alcohol withdrawal, migraine attacks, digestive disorders, muscle tension or cramps, and insomnia.

EMA: Press Release: EMA/CHMP/49123/2012 (20.1.12): European Medicines Agency recommends suspension of marketing authorisations for meprobamate-containing medicines in the European Union http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2012/01/WC500120728.pdf

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