Misoprostol Approved by European Medicines Agency for PPH Treatment

Linepharma, France, the pharmaceutical producer of Hemoprostol, has achieved the first approval of a misoprostol product for the treatment of postpartum hemorrhage (PPH). On January 23, 2014, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive scientific opinion of Hemoprostol for the treatment of PPH in accordance with Article 58 of Regulation (EC) No. 726/2004. The EMA has recommended one 800 microgram dose of Hemoprostol to be administered sublingually for the treatment of PPH caused by uterine atony. Together with Linepharma, Gynuity had prepared and submitted a dossier providing evidence on the use of misoprostol for PPH treatment, which underwent a formal review by the EMA. Data from Gynuity’s two large, multi-country studies on PPH treatment comparing the efficacy of misoprostol to intravenous oxytocin, the gold standard for PPH treatment, served as the main sources of research that would inform and lead to the EMA’s approval (Blum et al, 2010; Winikoff et al, 2010). Because of oxytocin’s widespread availability within the European Union, Hemoprostol is intended for sale only in markets outside the EU, where it is often less possible to provide oxytocin as cold storage and intravenous administration may not be feasible.

Detailed recommendations for the use of the product Hemoprostol can be found on the EMA website.