Ifosfamide solutions

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

Overview

EMA has started a review of certain medicines containing ifosfamide to examine whether there is a higher risk of encephalopathy (brain disorder) with ifosfamide available as a ready-made solution or concentrate for solution than with the powder form.

Ifosfamide is used to treat different types of cancers, including various solid tumours and blood cancers such as lymphomas (cancer of white blood cells). The risk of encephalopathy is already known and reflected in the product information for these medicines.

In 2016, an investigation in France suggested an incidence of encephalopathy 3 to 4-fold higher with the ready-made solution than with the powder. Analyses carried out at the time concluded that the risk may be linked to the degradation of the active substance and impurities developing over time in the solution. As a result, the solution’s shelf-life was reduced in France. However, two recent studies1 suggested that the risk of encephalopathy with the solution remains higher than the risk with the powder and a more thorough review was considered needed.

EMA will now assess the available data on the risk of encephalopathy with ifosfamide ready-made solution or concentrate for solution and recommend whether the marketing authorisations for these products should be maintained, varied, suspended or revoked.


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
Approved name
Ifosfamide solutions
International non-proprietary name (INN) or common name

ifosfamide

Associated names
  • Ifosfamide Eg
  • Ifo-Cell
  • Ifo-Cell N
  • Ifo-Cell N 2000
Class
alkylating agent
About this procedure
Current status
Under evaluation
Reference number
EMEA/H/A-31/1495
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
Procedure start date
12/03/2020

All documents

Procedure started

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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