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Medicinal products containing modified-release paracetamol: measures for risk minimisation and to reduce harm in case of overdose
2017.12.15
Active substance: paracetamol - modified release
15.12.2017 - CMDh decision
The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) confirms the PRAC recommendation that the marketing authorisations of medicinal products containing modified or prolonged release paracetamol shall be suspended (the active substance paracetamol is to be suspended over a longer period of time than with conventional fast-release products).
18. 07. 2016 - Procedure started
The BfArM issues information on the initiation of a European safety review according to Article 31 of Directive 2001/83/EC regarding medicinal products containing modified-release paracetamol. Standard procedures for treatment of paracetamol overdoses are possibly not suitable for overdoses with these medicinal products.
Medicinal products containing modified-release paracetamol are not licensed in Germany.
Further information
For details regarding the procedure please click on the following link to the European Medicines Agency (EMA):
To the risk assessment procedure (available in German only)