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Diane 35

This page shows the latest Diane 35 news and features for those working in and with pharma, biotech and healthcare.

EMA and FDA create pharmacovigilance 'cluster'

EMA and FDA create pharmacovigilance 'cluster'

In the 18 months since it launched, the PRAC has made safety recommendations on Ariad's cancer drug Iclusig (ponatinib) and Bayer's contraceptive Diane 35 (cyproterone acetate) among others.

Latest news

  • France investigates Teva after packaging mix-up France investigates Teva after packaging mix-up

    The furosemide recall is the second major patient safety event that the ANSM has investigated this year, following the recall of Bayer's contraceptive pill Diane 35 and its generics after

  • France ignores EMA and suspends Bayer's Diane 35 France ignores EMA and suspends Bayer's Diane 35

    Regulators in France have decided to suspend sales of Bayer's acne treatment Diane 35 despite a recommendation from the European Medicines Agency (EMA) that the drug's benefits outweighed its ... risks. Last week, the EMA's Pharmacovigilance Risk

  • EMA says Bayer's Diane 35 should remain on European market EMA says Bayer's Diane 35 should remain on European market

    Agency investigation concludes acne treatment's benefits outweigh its risks. Bayer's controversial acne treatment Diane 35 is to remain on the market in the EU after an investigation determined the ... The European Medicines Agency's (EMA)

  • Bayer’s Diane 35 faces ban in France Bayer’s Diane 35 faces ban in France

    There have also been 125 additional cases of thrombosis reported since 1987 in patients taking Diane 35 or one of its generics, with dozens still yet to recover fully. ... In the meantime, the EMA advises that women currently taking Diane 35 or a generic

  • EMA starts contraceptive safety probe EMA starts contraceptive safety probe

    company's older Diane 35 (ethinylestradiol and cyproterone) product, a combined oral contraceptive which is also used to treat acne. ... According to French newspaper Le Figaro, the agency is looking into reports of 125 women who suffered adverse events

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