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The QMN Weekly Bulletin

EMA to Pull Modified Release Paracetamol Products

Dec. 22, 2017

Modified-release products containing paracetamol will be suspended from the market in the European Union, the European Medicines Agency announced.

EMA’s Pharmacovigilance Risk Assessment Committee concluded that the longer-lasting products’ advantages do not outweigh the risks posed by managing overdoses.

PRAC said there are few known practical measures for reducing the products’ risks and there is no standardized method of adapting overdose management across the EU to cover both immediate- and modified-release products.

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