IPEC e-newsletter - Excipients Insight January 2018 - 20-01-18


Inside this issue


Long-acting paracetamol to be suspended in EU

Modified-release formulations of paracetamol are to be suspended from the EU market because the advantages of the products do not outweigh the complications of managing an overdose of the medicine.

The Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) – a regulatory group representing the EU, Iceland, Liechtenstein and Norway – says the suspension is needed since the treatment procedures for immediate-release products are not appropriate for modified-release paracetamol.

The medicines will remain suspended unless the companies that hold the marketing authorisations can provide evidence of appropriate and practical EU-wide measures to help prevent overdose with these products and adequately reduce its risks. Immediate-release paracetamol products, which are not affected by this review, will continue to be available as before.




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