Paracetamol modified-release

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

Overview

Modified-release paracetamol-containing products to be suspended from EU markete

On 13 December 2017 the CMDh1 endorsed by majority a European Medicines Agency recommendation to suspend marketing of modified- or prolonged-release products containing paracetamol (designed to release paracetamol slowly over a longer period than the usual immediaterelease products). The recommendation was made by the Agency's experts in medicines safety, the Pharmacovigilance Risk Assessment Committee (PRAC).

CMDh agreed with the Agency's advice that the advantages of a longer-acting product did not outweigh the complications of managing an overdose of the medicine, since the treatment procedures for immediate-release products are not appropriate for modified-release paracetamol. In many cases, it may not be known whether an overdose of paracetamol involves immediate-release or modifiedrelease products, making it difficult to decide how the overdose should be managed.

CMDh noted the PRAC conclusion that practical measures to sufficiently reduce the risk to patients had not been identified. Furthermore, it had not proved possible to agree a feasible and standardised way to adapt the management of overdose across the EU to cover both immediate- and modified-release paracetamol products. The CMDh therefore endorsed the PRAC recommendation that the marketing authorisations for medicines containing modified-release paracetamol, alone or combined with the opioid medicine tramadol, should be suspended.

The medicines will remain suspended unless the companies that hold the marketing authorisations can provide evidence of appropriate and practical EU-wide measures to help prevent overdose with these products and adequately reduce its risks.

Immediate-release paracetamol products, which are not affected by this review, will continue to be available as before.

Because the CMDh decision was agreed by majority vote it was sent to the European Commission which issued a final legally binding decision valid throughout the EU on 19/02/2018.


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

Key facts

About this medicine
Approved name
Paracetamol modified-release
International non-proprietary name (INN) or common name
paracetamol
Associated names
Alvedon
Class
analgesics/antipyretics
About this procedure
Current status
European Commission final decision
Reference number
EMEA/H/A-31/1445
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
07/07/2016
PRAC recommendation date
01/09/2017
CHMP opinion/CMDh position date
13/12/2017
EC decision date
19/02/2018
Outcome
Suspension

All documents

Procedure started

Recommendation provided by Pharmacovigilance Risk Assessment Committee

Position provided by CMDh

European Commission final decision

  • List item

    Paracetamol Article-31 referral - Modified-release paracetamol-containing products to be suspended from EU market (PDF/107.62 KB)


    First published: 01/03/2018
    Last updated: 01/03/2018
    EMA/118413/2018

  • List item

    Paracetamol Article-31 referral - Annex II (PDF/96 KB)


    First published: 01/03/2018
    Last updated: 01/03/2018

  • List item

    Paracetamol Article-31 referral - PRAC assessment report (PDF/1.01 MB)


    First published: 01/03/2018
    Last updated: 01/03/2018
    EMA/94286/2018

  • List item

    Paracetamol Article-31 referral - Modified-release paracetamol-containing products to be suspended from EU market (PDF/107.62 KB)


    First published: 01/03/2018
    Last updated: 01/03/2018
    EMA/118413/2018

  • List item

    Paracetamol Article-31 referral - Annex III (PDF/23.38 KB)


    First published: 01/03/2018
    Last updated: 01/03/2018

  • List item

    Paracetamol Article-31 referral - Annex I (PDF/173.67 KB)


    First published: 01/03/2018
    Last updated: 01/03/2018

  • List item

    Paracetamol Article-31 referral - CMDh divergent position (PDF/212.28 KB)


    First published: 01/03/2018
    Last updated: 01/03/2018

  • 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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