Methocarbamol / paracetamol-containing medicinal products

  • Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision
Current status
European Commission final decision

Overview

Benefits of medicines containing combination of methocarbamol and paracetamol continue to outweigh risks

On 26 March 2020, EMA concluded that the benefits of medicines containing methocarbamol and paracetamol continue to outweigh their risks in the short-term treatment of painful muscle spasms.

EMA’s review was started because recent publications* had raised questions about the effectiveness of the combination of these substances at treating conditions such as low back pain in the doses at which they are present in these medicines.

EMA’s human medicines committee (CHMP) considered all available data on medicines containing methocarbamol 380 mg and paracetamol 300 mg and concluded that the available evidence was not enough to question their effectiveness in the treatment of painful muscle spasms.

In addition, the Committee considered that the safety profile of each substance contained in these medicines is well known, and no new significant safety concerns were identified for the fixed dose combination. However, a few cases of dry mouth and diarrhoea have been reported and may be caused by methocarbamol. The Committee therefore recommended including these as side effects in the product information.


*Saragiotto BT, Machado GC, Ferreira ML, Pinheiro MB, Abdel Shaheed C, Maher CG. Paracetamol for low back pain. Cochrane Database Syst Rev. 2016 Jun 7;(6):CD012230, Emrich OM, Milachowski KA, Strohmeier M. Methocarbamol in acute low back pain. A randomized double-blind controlled study. MMW Fortschr Med. 2015 Jul;157 Suppl 5:9-16

Key facts

About this medicine
Approved name
Methocarbamol / paracetamol-containing medicinal products
International non-proprietary name (INN) or common name
  • methocarbamol
  • paracetamol
Associated names
Robaxisal compuesto
Class
Analgesic
About this procedure
Current status
European Commission final decision
Reference number
EMEA/H/A-31/1484
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.

Authorisation model
Nationally authorised product(s)
Decision making model
CHMP-EC
Key dates and outcomes
CHMP opinion date
26/03/2020
EC decision date
09/06/2020

All documents

Opinion provided by Committee for Medicinal Products for Human Use

European Commission final decision

  • List item

    Methocarbamol / paracetamol Article 31 referral - Benefits of medicines containing combination of methocarbamol and paracetamol continue to outweigh risks (PDF/137.51 KB)

    Adopted

    First published: 27/03/2020
    Last updated: 17/06/2020
    EMA/317184/2020

  • List item

    Methocarbamol / paracetamol Article 31 referral - Annex II (PDF/106.15 KB)


    First published: 17/06/2020

  • List item

    Methocarbamol / paracetamol Article 31 referral - Assessment report (PDF/373.78 KB)

    Adopted

    First published: 11/06/2020
    EMA/223791/2020

  • List item

    Methocarbamol / paracetamol Article 31 referral - Annex III (PDF/187.99 KB)


    First published: 27/03/2020
    Last updated: 17/06/2020

  • List item

    Methocarbamol / paracetamol Article 31 referral - Annex I (PDF/82.51 KB)


    First published: 29/05/2019
    Last updated: 17/06/2020
    EMA/298855/2019

  • 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.

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