EMA Safety Committee Starts Review of Leuprorelin Products

The EMA’s Pharmacovigilance Risk Assessment Committee said it is reviewing leuprorelin medicines after reports that handling errors during preparation and administration can cause some patients to receive insufficient amounts.

In its June 11-14 meeting, PRAC said it will evaluate the available data to see whether measures are needed to ensure that the medicines are prepared and administered appropriately.

The agency is advising healthcare professionals to carefully follow the handling instructions for leuprorelin products while the review is in progress.