EMA/PRAC starts review of leuprorelin medicines
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) stated following its June 11-14 meeting that it has started a review of leuprorelin medicines after reports indicated that handling errors during preparation and administration can cause some patients to receive insufficient amounts of their medicine, thus reducing the benefits of treatment.
The review of the benefit-risk balance followed notification by Germany of a referral under Article 31 of Directive 2001/83/EC, based on pharmacovigilance data.
The PRAC will now evaluate all available data and determine whether measures are needed to ensure that the medicines are prepared and administered appropriately.
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