Leuprorelin-containing depot medicinal products
- Procedure started
- Under evaluation
- PRAC recommendation
- CMDh final position
Table of contents
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
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Approved name |
Leuprorelin-containing depot medicinal products
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International non-proprietary name (INN) or common name |
leuprorelin
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Associated names |
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About this procedure
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Current status |
CMDh final position
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Reference number |
EMEA/H/A-31/1486
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Type | |
Authorisation model |
Nationally authorised product(s)
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Decision making model |
PRAC-CMDh
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Key dates and outcomes
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PRAC recommendation date |
14/05/2020
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CHMP opinion/CMDh position date |
24/06/2020
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All documents
Procedure started
Leuprorelin-containing depot medicines Article-31 referral - Review of handling errors with depot formulations of leuprorelin medicines started (PDF/76.81 KB)
First published: 14/06/2019
EMA/316598/2019
Leuprorelin-containing depot medicines Article-31 referral - Notification (PDF/61.25 KB)
First published: 14/06/2019
Leuprorelin-containing depot medicines Article-31 referral - List of questions (PDF/88.45 KB)
First published: 14/06/2019
EMA/PRAC/317692/2019
Leuprorelin-containing depot medicines Article-31 referral - Timetable for the procedure (PDF/111.61 KB)
First published: 14/06/2019
Last updated: 16/03/2020
EMA/PRAC/317693/2019 Rev 2
Recommendation provided by Pharmacovigilance Risk Assessment Committee
Position provided by CMDh
Leuprorelin-containing depot medicines Article-31 referral - Annex IV (PDF/57.73 KB)
First published: 31/07/2020
Leuprorelin-containing depot medicines Article-31 referral - Annex II (PDF/74.77 KB)
First published: 31/07/2020
Leuprorelin-containing depot medicines Article-31 referral - Public assessment report to PRAC recommendation (PDF/2.1 MB)
First published: 29/07/2020
EMA/397961/2020
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
Leuprorelin-containing depot medicines Article-31 referral - Annex III (PDF/92.91 KB)
First published: 26/06/2020
Leuprorelin-containing depot medicines Article-31 referral - Annex I (PDF/138.14 KB)
First published: 14/06/2019
Last updated: 31/07/2020
Description of documents published
Please note that some of the listed documents apply only to certain procedures.
- Overview - lay-language summary of the stage of the procedure
- Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
- Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
- List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
- Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
- List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
- List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
- Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
- Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
- Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
- Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
- Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
- Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
- Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
- Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)
Note that older documents may have different titles.
News
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15/05/2020
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14/02/2020
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17/01/2020
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31/10/2019
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11/07/2019
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14/06/2019