EMA: Nitrosamines Appendix 1 Updated
An update of the Appendix 1 (“Acceptable intakes established for N-nitrosamines”) of the Questions and answers for marketing authorization holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products has just been published by the EMA.
In this revision new acceptable intakes have been proposed for new N-nitrosamines in, among others, rivaroxaban, furosemide and dextromethorphan.
Source:
EMA Nitrosamines: Appendix 1
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