Leuprorelin-containing depot medicinal products

Current status:
Procedure started

Overview

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.

This review covers formulations called depot formulations which are given by injection under the skin or into a muscle and release the active substance slowly over 1 to 6 months. These include implants as well as powders and solvents for the preparation of injections.

Several of these formulations require complex steps to prepare the injection. Handling errors with these formulations have reportedly led to problems such as leakages from the syringe or failure to deliver implants from the applicator.

EMA’s safety committee, PRAC, will now evaluate all available data and determine whether measures are needed to ensure that the medicines are prepared and administered appropriately.

While the review is ongoing, healthcare professionals should carefully follow the handling instructions for leuprorelin medicines. Patients prescribed leuprorelin medicines who have any concerns should discuss them with their doctor.

Key facts

Approved name
Leuprorelin-containing depot medicinal products
International non-proprietary name (INN) or common name

leuprorelin

Associated names
See "List of the medicines affected by the referral (Annex I)"
Reference number
EMEA/H/A-31/1486
Type
Article 31 referrals

This type of referral is triggered when the interest of the Union is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.

Status
Procedure started

All documents

Document description

  • Questions and answers (Q&A) - easy-to-understand summary of key issues and Committee conclusions
  • Summary of Opinion - contains the CHMP opinion of the referred medicine(s)
  • List of the medicines affected by the referral (Annex I)
  • Scientific conclusions of the Committee (Annex II)

The following two documents are sometimes available:

News

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