Upon the decision of the European Medicines Agency (EMA) to suspend the marketing authorisations for all medicines containing 17-hydroxyprogesterone caproate (17-OHPC) as an active substance in the EU Member States, the Institute for medicines and medical devices informs the public that it initiated procedures within its jurisdiction. Namely, in cooperation with the marketing authorisation holder for Progesteron Depo, solution for injection, 250 mg/ml, in July this year the Institute informed healthcare professionals prescribing and dispensing this medicine that its marketing authorisation would cease to be valid and the medicine would no longer be available in Montenegro.
Upon assessing the benefit-risk ratio for medicines containing 17-hydroxyprogesterone caproate (17-OHPC) and concluding that it was no longer positive, the European Union decided to suspend the marketing authorisations for all medicines containing this substance by 24 August 2024.
The benefit-risk ratio for medicines containing this substance was examined in studies the aim of which was to examine possible connection between the use of this form of progesterone and the occurrence of cancer in persons who were exposed to 17-hydroxyprogesterone caproate in the uterus. The study showed that the risk of the occurrence of cancer was possible, but it could not be confirmed due to the limitations of the study, i.e. the existence of a large number of factors that could influence the occurrence of cancer. The results of the mentioned study refer exclusively to medicines containing this form of progesterone. Additionally, the conclusion is that the medicine does not have a satisfactory level of efficacy in relation to the possible risk, so the overall benefit-risk ratio is no longer considered positive.
Marketing authorisation holder for Progesteron Depo submitted the application for cessation of validity of marketing authorisation to the Institute for medicines and medical devices. Additionally, according to the information provided by the marketing authrisation holder, the medicine in question was last time imported in March 2024, and at the moment of delivery of the notification by the EMA, the Institute received information from the marketing authorisation holder that the medicine in question was out of stock at the distributors.
Please note that medicines containing other forms of progesterone are available in Montenegro and are not affected by the aforementioned decision, so healthcare professionals may consider alternative treatment options. It is necessary for patients to consult with their doctors about the continuation of the therapy. Also, please note that the Institute has not received reports of suspected adverse reactions to this medicine that would require taking regulatory measures in accordance with the Law.
In accordance with European standards, the Institute will continue to monitor and implement all decisions made by the scientific committees of the European Medicines Agency and the European Commission and to take appropriate regulatory measures in cooperation with marketing authorisation holders and healthcare professionals.
