Pharmacovigilance Risk Assessment Committee (PRAC) invites stakeholders' feedback in review of Diane 35 and its generics

News 12/02/2013

As part of the safety review of Diane 35 and other medicines containing cyproterone acetate 2 mg and ethinylestradiol 35 micrograms, the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) is inviting all stakeholders, e.g., healthcare professionals, patients' organisations and the general public, to submit data relevant to the procedure so that they can be considered during the review. This new tool allows the PRAC to actively engage stakeholders in the evaluation process and will facilitate prompt and efficient processing of stakeholders' concerns.

Data can be submitted using a specific form, which is available under the data submission tab on the referral page for cyproterone- and ethinylestradiol-containing medicines.

All data should be submitted by 11 March 2013.

The PRAC started a safety review of Diane 35 (cyproterone acetate 2 mg / ethinylestradiol 35 micrograms), associated names and its generics at its 4-7 February 2013 meeting.

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