EMA tells drugmakers to review medicines for possible presence of nitrosamines

With nitrosamines impurities now identified in ranitidine and ‘sartan’ medicines, the European Medicines Agency’s human medicines committee (CHMP) is requesting as a matter of precaution that marketing authorization holders for human medicines containing chemically synthesised active substances review their medicines for the possible presence of nitrosamines and test all products at risk.

If nitrosamines are detected in any of their medicines, marketing authorization holders must inform authorities promptly so that appropriate regulatory actions can be taken.

A  notice to this effect is being sent out to marketing authorisation holders with information on the actions they should take. A  questions-and-answers document is also available on EMA’s website.