Leuprorelin-containing depot medicinal products

Depot formulations of leuprorelin medicines are formulations that release the active substance gradually. These formulations are used to treat prostate cancer, breast cancer and conditions that affect the female reproductive system (endometriosis, symptomatic uterus myomatosus, uterine fibrosis and early puberty). They include implants as well as powders and solvents for the preparation of injections.

Leuprorelin medicines are also available as daily injections but this formulation is not included in the review as there have been no reports of handling errors with this formulation.

Leuprorelin medicines have been authorised via national procedures. They are marketed in many EU countries and are available under several brand names, including Eligard, Eliprogel, Enantone, Ginecrin, Lupron, Lutrate, Politrate, and Procren.

The review of leuprorelin depot medicines has been initiated at the request of Germany, under Article 31 of Directive 2001/83/EC.

The review is being carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which will make a set of recommendations. As leuprorelin medicines are all authorised nationally, the PRAC recommendations will be forwarded to the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), which will adopt a position. The CMDh is a body representing EU Member States as well as Iceland, Liechtenstein and Norway. It is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.