EMA: Revision 6 of the Appendix 1 on AIs for N-Nitrosamines
EMA published the revision 6 of the Appendix 1 (“Acceptable intakes (AIs) established for N-nitrosamines”) of the EMA 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 (EMA/409815/2020 Rev.21).
In this revision, new acceptable intakes (AIs) were proposed for N-nitrosamines in APIs such as acebutol, buspirenone, ciprofloxacin, dimetindene, diclofenac, maprotiline, melipramin, propafenone, rivastigmine, valsartan, vanzacaftor and vildagliptin.
The acceptable intakes of N-nitrosamines in amitriptyline, ciprofloxacin, diclofenac, nortryptyline and sertraline have also been updated.
Source:
EMA: Nitrosamine Impurities, Appendix 1
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