Methocarbamol / paracetamol-containing medicinal products

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

Overview

EMA begins review of the effectiveness of medicines containing methocarbamol and paracetamol

EMA has started a review of the effectiveness of medicines containing a combination of methocarbamol and paracetamol for the treatment of painful muscle spasms. The review is being carried out at the request of the German medicines agency, BfArM, which has been asked to evaluate a marketing application for a  PDF icongeneric medicine  based on Robaxisal compuesto, a medicine authorised in Spain for painful muscle spasms associated with various short-term muscle disorders, such as low back pain.

Robaxisal compuesto, which has been authorised for many years, contains methocarbamol, a medicine that reduces muscle spasm and paracetamol, which is a painkiller. However, more recent evidence suggests that these two substances, in the doses in which they are combined in the medicine, might not be effective in the conditions such as low back pain for which it is currently used. Therefore the German agency has asked EMA to review the effectiveness of the combination.

Key facts

Approved name
Methocarbamol / paracetamol-containing medicinal products
International non-proprietary name (INN) or common name

methocarbamol/paracetamol

Associated names
Robaxisal compuesto
Class
Analgesic
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.

Status
Procedure started
Opinion date
29/05/2019

All documents

Document description

  • Questions and answers (Q&A) - easy-to-understand summary of key issues and Committee conclusions
  • Summary of Opinion - contains the CHMP opinion of the referred medicine(s)
  • List of the medicines affected by the referral (Annex I)
  • Scientific conclusions of the Committee (Annex II)

The following two documents are sometimes available:

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