03.08.2020 - European Commission final decision

With regard to the combination drug methocarbamol/paracetamol 380 mg/300 mg, the final decision of the EU Commission was issued on 10.06.2020.

09.04.2020 - CMDh opinion

In the procedure under Art. 31 of Directive 2001/83/EC, the European Medicines Agency EMA concluded that the benefits of medicinal products containing the active substances methocarbamol and paracetamol combined still outweigh the risks in the short-term treatment of painful muscle spasms.

29.05.2019 - Procedure started

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.

The medicine ist not yet marketed in Germany.

Further information

For details on the procedure please click on the following link to the homepage of the European Medicines Agency (EMA):

Methocarbamol/paracetamol-containing medicinal products