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29.02.2024

EMA: 14 New/Updated Acceptable Intakes for N-nitrosamines

EMA: 14 New/Updated Acceptable Intakes for N-nitrosamines

An update of the EMA's Appendix 1 to the questions and answers for marketing authorisation holders/applicants on nitrosamine impurities in human medicinal products has just been published (EMA/72902/2024 /Rev. 3).


In this update, new acceptable intakes (AIs) have been proposed for 14 nitrosamines, determined using the Carcinogenic Potency Categorization Approach (CPCA) for N-nitrosamines.

Source:

EMA: Nitrosamin impurities


 

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