06.08.2020 - Notice within the graduated plan procedure (“Stufenplanverfahren”)

The PRAC recommendations were adopted by the Co-ordination Group for Mutual Recognition and Decentralised Procedures – human (CMDh) by consensus on 25 June 2020. The Federal Institute for Drugs and Medical Devices (BfArM) has implemented the decision of the CMDh at national level by an official notice, dated 29 July 2020. Due to divergent obligations within the CMDh position, the marketing authorisation holders Astellas and GP Pharm received a separate notice.

26.06.2020 - CMDh position

On 14th May 2020 the Pharmacovigilance Risk Assessment Committee (PRAC) of the EMA recommended measures to avoid application errors in the preparation and administration of depot drugs containing leuprorelin.

15.05.2020 - PRAC recommendation

EMA’s safety committee (PRAC) is recommending measures to avoid handling errors in the preparation and administration of leuprorelin depot medicines.

14.06.2019 - Procedure started

Review of handling errors with depot formulations of leuprorelin medicines started

EMA has started a review of leuprorelin medicines after reports indicated that handling errors with the products during preparation and administration can cause some patients to receive insufficient amounts of their medicine, thus reducing the benefits of treatment.

Further information

For details on the procedure please click on the following link to the homepage of the European Medicines Agency (EMA):

Leuprorelin-containing depot medicinal products