Document

Filter documents Clear search

pdf icon

FSRH CEU Statement: Strengthening of Warnings about use of Dianette and other brands of co-cyprindiol (June 2013)

File size: 58kb | Date: 1 June 2013 | Clinical Statements - PDF

Following a recent safety review, a letter has been issued to healthcare professionals from the manufacturers of DianetteĀ® and other cyproterone acetate 2 mg/ ethinylestradiol 35 mcg (co-cyprindiol) products. The review by the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) followed concerns about the risk of thrombosis associated with co-cyprindiol. With the agreement of the EMA and Medicines and Healthcare products Regulatory Authority (MHRA), a letter has been issued to raise awareness of the thrombosis risks and the outcome of the review.