Methotrexate containing medicinal products
- Procedure started
- Under evaluation
- PRAC recommendation
- CHMP opinion
- European Commission final decision
Table of contents
Overview
New measures to avoid potentially fatal dosing errors with methotrexate for inflammatory diseases
On 22 August 2019 EMA recommended new measures to prevent serious and potentially fatal errors with the dosing of methotrexate for treating inflammatory diseases such as rheumatoid arthritis, psoriasis and Crohn’s disease. The recommendations result from a review of reports that patients are using methotrexate incorrectly despite previous measures to prevent errors.
For inflammatory conditions, methotrexate must be used just once a week. Using methotrexate more frequently than intended can result in serious side effects. The review found that the error in dosing frequency can occur at any step from prescribing the medicine to the patient taking it.
The new measures to prevent errors include restricting who can prescribe these medicines, making warnings on the packaging more prominent and providing educational materials for patients and healthcare professionals. In addition, to help patients follow the once-weekly dosing, methotrexate tablets will be provided in blister packs and not in bottles (or tubes). The measures were agreed after consultation with patients and healthcare professionals.
Key facts
About this medicine
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Approved name |
Methotrexate containing medicinal products
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International non-proprietary name (INN) or common name |
methotrexate
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Associated names |
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About this procedure
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Current status |
European Commission final decision
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Reference number |
EMEA/H/A-31/1463
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Type | |
Authorisation model |
Centrally and nationally authorised products (mixed)
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Decision making model |
PRAC-CHMP-EC
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Key dates and outcomes
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Procedure start date |
12/04/2018
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PRAC recommendation date |
11/07/2019
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CHMP opinion/CMDh position date |
22/08/2019
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EC decision date |
21/10/2019
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Outcome |
Risk minimisation measures
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All documents
Procedure started
Methotrexate Article-31 referral - Notification (PDF/278.9 KB)
First published: 13/04/2018
Last updated: 13/04/2018
Methotrexate Article-31 referral - Review started (PDF/94.26 KB)
First published: 13/04/2018
Last updated: 13/04/2018
Methotrexate Article-31 referral - Timetable for the procedure (PDF/76.48 KB)
First published: 13/04/2018
Last updated: 17/05/2019
EMA/PRAC/199744/2018 Rev.3
Methotrexate Article-31 referral - Annex I (PDF/987.44 KB)
First published: 13/04/2018
Last updated: 18/06/2018
Methotrexate Article-31 referral - PRAC list of questions (PDF/105.98 KB)
First published: 13/04/2018
Last updated: 13/04/2018
Recommendation provided by Pharmacovigilance Risk Assessment Committee
Opinion provided by Committee for Medicinal Products for Human Use
Methotrexate Article-31 referral - Nordimet : EPAR - Product Information
First published: 31/10/2019
Methotrexate Article-31 referral - Jylamvo : EPAR - Product Information (PDF/355.11 KB)
First published: 31/10/2019
Methotrexate Article-31 referral - Annex IV (PDF/17.07 KB)
First published: 31/10/2019
Methotrexate Article-31 referral - Annex II (PDF/48.08 KB)
First published: 31/10/2019
Methotrexate Article-31 referral - Annex I (PDF/908.39 KB)
First published: 31/10/2019
Methotrexate Article-31 referral - Annex III (PDF/37.96 KB)
First published: 23/08/2019
Last updated: 31/10/2019
Methotrexate Article-31 referral - New measures to avoid potentially fatal dosing errors with methotrexate for inflammatory diseases (PDF/123.06 KB)
First published: 23/08/2019
EMA/414775/2019
European Commission final decision
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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23/08/2019
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12/07/2019
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17/05/2019
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07/09/2018
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13/07/2018
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15/06/2018
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13/04/2018
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13/04/2018