Reducing risks to human and animal health from exposure to N-methyl pyrrolidone in veterinary medicines – www.ema.europa.eu

14 Apr, 2023

www.ema.europa.eu

On 8 December 2022, EMA’s veterinary medicines committee, the CVMP, recommended new measures to reduce the risks from exposure to the excipient N-methyl pyrrolidone (NMP) for women who may handle NMP-containing veterinary medicines and animals that are given these medicines. The recommendations address inconsistencies in the product information of veterinary medicines containing NMP, which are marketed in many European Union (EU) Member States. For more details on the CVMP recommendations, please consult the procedure page.

NMP is an excipient used in some veterinary medicines that is classified as a teratogen (a substance that can cause birth defects following exposure during pregnancy) in laboratory animals. There is therefore the possibility that NMP could cause birth defects in children of women who handle or come into contact with NMP-containing medicines during their pregnancy, and in the offspring of animals given these medicines.

More than 1,100 veterinary…

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