EMA’s safety committee started a review of leuprorelin medicines
26 June 2019 – The safety committee the Pharmocovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency has started a review of leuprorelin medicines as reports recently indicated that handling errors with the products during preparation and administration can cause some patients to receive insufficient amounts of their medicine, which again is reducing the benefits of the treatment. The PRAC’s review covers depot formulations, i.e. injections under the skin or into a muscle which release the active substance slowly over 1 to 6 months. These formulations require complex steps to prepare an injection which led to problems such as leakages from the syringe or failure to deliver implants from the applicator (for further information, see here).