N-nitroso-quinapril

Nitrosamines in the News
10

Dear all,
Please note that the EMA allowed a temporary AI (t-AI) of 178 ng/day
(total nitrosamines) for max 12 months (Q21), but this is valid for EU countries only; other authorities (e.g.FDA) may have a different approach.

Questions and answers for marketing authorisation 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 (rev.14)

kind regards

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