Policy & Regulation
EMA confirms marketing authorisation for 3rd, 4th-generation pills
14 January 2013 - 14 January 2013 - The European Medicines Agency (EMA) reiterated on Friday the marketing authorisation for third- and fourth-generation contraceptive pills, since there was no new proof to cause a change in the safety profile of the drugs.

There is no reason for women to stop taking these pills, EMA said.

French healthcare minister Marisol Touraine has asked, on the other hand, that the marketing authorisations for these pills are limited to second-choice prescriptions. Furthermore, the healthcare authorities in France will work towards tightening the control over the use of such birth control pills, because of the risk of health complications, more specifically phlebitis.

Recently, the French healthcare and social affairs ministry announced that the reimbursement of third-generation contraceptive pills will be stopped on March 31, 2013. According to French drug safety agency ANSM, third-generation contraceptive pills are too widely used in France.

A complaint has already been filed against this pill in December 2012 and a further 30 are seen to be submitted in January 2013.
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