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Methocarbamol/paracetamol-containing medicinal products: benefits continue to outweigh risks
2020.08.03
Active substance: methocarbamol | paracetamol
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):