Ifosfamide solutions
- Procedure started
- Under evaluation
- PRAC recommendation
- CMDh position
- European Commission final decision
Table of contents
Overview
Benefits of ifosfamide solutions continue to outweigh risks
On 11 March 2021, EMA’s safety committee (PRAC) concluded that the benefits of ifosfamide solutions for infusion continue to outweigh their risks in the treatment of different types of cancers, including various solid tumours and blood cancers such as lymphomas (cancer of white blood cells).
The PRAC review was started because two recent studies , suggested that the risk of encephalopathy (brain disorders) with ifosfamide supplied in solution forms is higher than with the powder form. Ifosfamide-induced encephalopathy is a very common, known risk and is generally reversible.
PRAC considered all available data and concluded that an increased risk of encephalopathy with ifosfamide supplied as a solution could neither be confirmed nor excluded due to limitations in the data. PRAC recommended that the existing warning on ifosfamide-induced encephalopathy in the product information should be updated with the latest information on this side effect, including its characteristics and risk factors, as well as highlighting the need to closely monitor patients.
Companies that market ifosfamide supplied as a solution will be required to carry out studies investigating the stability of the medicines in order to establish the optimal storage conditions.
1 Hillaire-Buys D, Mousset M, Allouchery M, et al. Liquid formulation of ifosfamide increased risk of encephalopathy: A case-control study in a pediatric population. Therapies [Online]. 2019
2 Chambord J, Henny F, Salleron J, et al. Ifosfamide‐induced encephalopathy: Brand‐name (HOLOXAN®) vs generic formulation (IFOSFAMIDE EG®). J Clin Pharm Ther. 2019;44:372–380.
Key facts
About this medicine
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Approved name |
Ifosfamide solutions
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International non-proprietary name (INN) or common name |
ifosfamide
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Associated names |
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Class |
alkylating agent
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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-31/1495
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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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Procedure start date |
12/03/2020
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PRAC recommendation date |
11/03/2021
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CHMP opinion/CMDh position date |
21/04/2021
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EC decision date |
21/06/2021
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Outcome |
Risk minimisation measures
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All documents
Procedure started
Ifosfamide solutions Article-31 referral - Notification (PDF/3.66 MB)
First published: 13/03/2020
Ifosfamide solutions Article-31 referral - Annex I (PDF/112.43 KB)
First published: 13/03/2020
EMA/135187/2020
Ifosfamide solutions Article-31 referral - PRAC list of questions (PDF/218.3 KB)
First published: 13/03/2020
EMA/PRAC/111337/2020
Ifosfamide solutions Article-31 referral - Review started (PDF/167.45 KB)
First published: 13/03/2020
EMA/116503/2020
Under evaluation
Recommendation provided by Pharmacovigilance Risk Assessment Committee
Position provided by CMDh
European Commission final decision
Ifosfamide solutions Article-31 referral - Annex I (PDF/117.13 KB)
First published: 19/07/2021
Ifosfamide solutions Article-31 referral - Annex II (PDF/132.68 KB)
First published: 19/07/2021
Ifosfamide solutions Article-31 referral - Annex III (PDF/183.89 KB)
First published: 19/07/2021
Ifosfamide solutions Article-31 referral - Annex IV (PDF/111.82 KB)
First published: 19/07/2021
Ifosfamide solutions Article-31 PhV - CMDH divergent positions (PDF/67.17 KB)
First published: 19/07/2021
Ifosfamide solutions Article-31 referral - Assessment Report (PDF/785.85 KB)
First published: 29/06/2021
EMA/159195/2021
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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12/03/2021
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12/03/2021
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12/02/2021
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30/10/2020
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02/10/2020
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04/09/2020
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10/07/2020
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12/06/2020
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13/03/2020