EllaOne to be available without prescription

EllaOne (ulipristal acetate), an emergency contraceptive, is to be made available without a prescription from community pharmacies throughout the European Union.

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended a change in the classification of the drug from prescription to non-prescription status. The move follows a request for the change from the licence holder Laboratoire HRA Pharma.

After reviewing all the available data, the CHMP found that EllaOne demonstrates a safety profile similar to that of levonorgestrel-containing emergency contraceptives, which are already available without a prescription in 23 European countries.

The EMA states that the drug works best when taken within 24 hours of unprotected sex or contraceptive failure. “Removing the need to get a prescription for this drug should speed up women’s access to it and therefore increase its effectiveness,” it adds.

The CHMP recommendation will now be put before the European Commission for a legally binding decision.

The Royal Pharmaceutical Society (RPS) has welcomed the change. “This reclassification is a benefit to public health as it widens the options for women at risk of unplanned pregnancy while maintaining professional standards of provision,” says RPS president Ash Soni. 

Last updated
The Pharmaceutical Journal, PJ, 6/13 December 2014, Vol 293, No 7839/40;293(7839/40):DOI:10.1211/PJ.2014.20067243

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