Press Release: European Medicines Agency update on Diane 35 and generics used in the treatment of acne

Author (Corporate)
Series Title
Series Details EMA/65929/2013-corr (31.01.13)
Publication Date 31/01/2013
Content Type

The French medicines agency (ANSM), on 31 January 2013, announced its plan to suspend the marketing authorisation for Diane 35 and its generics for acne treatment in France within three months. The Agency considered that Diane 35 and its generics carried a risk of thromboembolism.
Source Link http://www.emea.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2013/01/news_detail_001703.jsp&mid=WC0b01ac058004d5c1
Related Links
EMA: Press Release: EMA/65929/2013-corr (31.01.13) http://www.emea.europa.eu/docs/en_GB/document_library/Press_release/2013/01/WC500138302.pdf
EMA: Press Release: EMA/82707/2013 (08.02.13): European Medicines Agency starts safety review of Diane 35 and its generics http://www.emea.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2013/02/news_detail_001711.jsp&mid=WC0b01ac058004d5c1
EMA: Press Release: EMA/PRAC/284754/2013 (17.05.13):Benefits of Diane 35 and generics outweigh risks in specific patient group http://www.emea.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2013/05/news_detail_001790.jsp&mid=WC0b01ac058004d5c1
EMA: Press Release: EMA/318380/2013 (30.05.13): Benefits of Diane 35 and its generics outweigh risks in certain patient groups - PRAC recommendation endorsed by CMDh http://www.emea.europa.eu/docs/en_GB/document_library/Press_release/2013/05/WC500143774.pdf
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