EMA: Nitrosamine Impurities – New: Champix Section
In February 2025, EMA's CHMP adopted a positive opinion approving changes to the manufacturing process for Champix, a smoking cessation medicine.
These changes ensure that the levels of nitrosamine impurity N-nitroso-varenicline present in Champix stay below the acceptable intake limit during manufacture and throughout the product’s shelf-life.
In 2021, the CHMP carried out a review of the presence of N nitroso-varenicline in Champix. The CHMP concluded that the marketing authorisation holder should make changes to Champix's authorisation to ensure that it conforms to acceptable nitrosamine intake limits for EU medicines. These limits are calculated in line with the ICH M7 guideline.
As a precaution, the marketing authorisation holder recalled several batches and paused distribution of Champix as of June 2021.
Source:
EMA: Nitrosamine impurities in specific medicine
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