Privately-held French company HRA Pharma says that its novel emergency contraceptive ellaOne (ulipristal acetate) has received approval for reimbursement by France’s Ministry of Health. The official decision was made public in the September 15 issue of the Official Journal of the Government of France. As a result, ellaOne is now available as a reimbursed drug, on prescription only.
“We are very pleased to have obtained reimbursement in France for ellaOne,” said Erin Gainer, chief executive of HRA Pharma, noting that the “French health authorities have a particularly rigorous review process: the inclusion of ellaOne on the list of drugs eligible for reimbursement is a testament to the robust body of clinical evidence that supports the product’s efficacy and safety. It is also an important milestone for emergency contraception in France, demonstrating that France remains a country committed to progress in this sector.”
ellaOne prevents pregnancy when taken orally within 120 hours (five days) of unprotected sex or contraceptive failure. Ulipristal acetate, the active ingredient that composes ellaOne, is a selective progesterone receptor modulator with antagonistic and partial agonistic effects at the progesterone receptor. Its primary mechanism of action is inhibition or delay of ovulation. This prescription-only emergency contraceptive product has been available in Europe since October 2009.
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