Leuprorelin-containing depot medicinal products

  • Procedure started
  • Under evaluation
  • PRAC recommendation
  • CMDh final position
Current status:
CMDh final position

Overview

New measures to avoid handling errors with leuprorelin depot medicines

On 14 May 2020, EMA’s safety committee (PRAC) recommended measures to avoid handling errors in the preparation and administration of leuprorelin depot medicines.

A review by the PRAC found that handling errors resulted in some patients receiving insufficient amounts of their medicine. The errors reported included incorrect use of the needle or syringe, causing the medicine to leak from the syringe, and failure to inject leuprorelin properly.  

The Committee therefore recommended that only healthcare professionals familiar with the preparation steps for leuprorelin depot medicines should prepare and administer the medicines to patients. Patients should not prepare or inject these medicines themselves. 

The Committee also made recommendations for particular leuprorelin depot medicines. For the medicine Eligard, the product information is to be updated with warnings to strictly follow the instructions for preparation and administration and to monitor patients if a handling error occurs. In addition, the company marketing Eligard must replace the current device used to administer the medicine with one that is easier to handle. The regulatory application for this modification should be submitted by October 2021.

For another medicine, Lutrate Depot, the PRAC recommended that instructions for handling the medicine be revised to make them easier to follow and its packaging changed so the instructions are easier to find.

Depot formulations of leuprorelin are used to treat prostate cancer, breast cancer, certain conditions that affect the female reproductive system, and early puberty. Several formulations require complex steps to prepare the injection.

The PRAC recommendations were adopted by the CMDh1 by consensus and will be implemented directly at national level.


1 The CMDh is a medicines regulatory body representing the European Union (EU) Member States, Iceland, Liechtenstein and Norway.

Key facts

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

leuprorelin

Associated names
  • Daronda
  • Depo-Eligard
  • Eligard
  • Eligard Depot
  • Eligard Mensua
  • Eligard Semestral
  • Eligard Trimestral
  • Elityran 1 Month Depot (Dps)
  • Elityran 3 Month Depot (Dps)
  • Enanton Depot Dual
  • Enanton Depot Set
  • Enantone
  • Enantone L.P
  • Enantone Lp
  • Enantone Monats-Depot
  • Ginecrin Depot
  • Klebrocid 3-Monats-Depot
  • Klebrocid Depot Zweikammerspritze
  • Leptoprol
  • Lerin
  • Leugon
  • Leuprex 3
  • Leuprol
  • Leuprolin Ratiopharm
  • Leuprone 1-Monatsdepot
  • Leuprone 3-Monatsdepot
  • Leuprorelin 1-Month Depot Gp-Pharm
  • Leuprorelin Hexal
  • Leuprorelin Sandoz
  • Leuprorelina Gp-Pharm
  • Leupro-Sandoz 1-Monats-Depot
  • Leupro-Sandoz 3-Monats-Depot
  • Leuprorelina Trimestral Sandoz
  • Leuprostin
  • Leuproreline Sandoz
  • Lucrin
  • Lucrin Depot
  • Lucrin Pds Depot
  • Lucrin Pds Depot 1 Maand
  • Lucrin Pds Depot 3 Maanden
  • Lucrin Pds Depot 6 Maanden
  • Lupron Depo
  • Lutrate 1 Month Depot
  • Lutrate 3 Month Depot
  • Lutrate Depo
  • Lutrate Depot
  • Lutrate Depot Trimestral
  • Politrate
  • Politrate Politrate Depot
  • Procren Depot
  • Procren Depot Pds
  • Procrin Mensual
  • Procrin Semestral
  • Procrin Trimestral
  • Prostap 3 Dcs
  • Prostap 6 Dcs
  • Prostap Sr Dcs
  • Prostaplant
  • Sixantone
  • Trenantone
  • Trenantone-Gyn
  • Zeulide
  • Елигард
  • Лутрат Депо
About this procedure
Current status
CMDh final position
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.

Decision making model
PRAC-CMDh
Authorisation model
Nationally authorised product(s)
Key dates and outcomes
PRAC recommendation date
14/05/2020
CHMP opinion/CMDh position date
24/06/2020

All documents

Procedure started

Recommendation provided by Pharmacovigilance Risk Assessment Committee

Position provided by CMDh

  • List item

    Leuprorelin-containing depot medicines Article-31 referral - Annex IV (PDF/57.73 KB)


    First published: 31/07/2020

  • List item

    Leuprorelin-containing depot medicines Article-31 referral - Annex II (PDF/74.77 KB)

    Adopted

    First published: 31/07/2020

  • List item

    Leuprorelin-containing depot medicines Article-31 referral - Public assessment report to PRAC recommendation (PDF/2.1 MB)

    Adopted

    First published: 29/07/2020
    EMA/397961/2020

  • List item

    Leuprorelin-containing depot medicines Article-31 referral - Timetable for the implementation of the CMDh position (Annex V) (PDF/41.34 KB)


    First published: 26/06/2020

  • List item

    Leuprorelin-containing depot medicines Article-31 referral - Annex III (PDF/92.91 KB)


    First published: 26/06/2020

  • List item

    Leuprorelin-containing depot medicines Article-31 referral - Annex I (PDF/138.14 KB)


    First published: 14/06/2019
    Last updated: 31/07/2020

  • Document description

    • Annex I - List of the medicines affected by the referral
    • Annex II - Scientific conclusions of the CHMP or CMDh
    • Annex III - Changes to the summary of product characteristics, labelling or package leaflet - available when the CHMP or CMDh recommends changes to the product information. Also includes conditions for lifting of suspensions, if applicable
    • Annex IV - Conditions of the marketing authorisation - available when the CHMP or CMDh recommends other measures to be taken for the marketing authorisation such as safety measures or additional studies
    • Notification - A letter from a Member State, the European Commission or a marketing-authorisation holder requesting the initiation of a referral procedure
    • Rationale for triggering - Background provided by the party triggering the referral explaining the issues leading to the initiation of the procedure
    • PRAC list of questions - Questions agreed by the PRAC requesting further information to evaluate the issues identified
    • PRAC timetable - Timeframe agreed by the PRAC to receive information, assess the issues and adopt a recommendation
    • PRAC / CHMP or CMDh assessment report - The assessment and conclusions of the PRAC and CHMP or CMDh on the issues investigated

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