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EDQM’s actions to evaluate impact of impurity in ranitidine medicines

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Certification of suitability (CEP)
News
16 September 2019
Strasbourg, France

The EDQM is aware of a quality defect in ranitidine medicines used to treat heartburn and stomach ulcers. An impurity called N-nitrosodimethylamine (NDMA) was detected in some of these medicines.

Last week, the European Medicines Agency (EMA) announced that it was starting a review of medicines containing ranitidine at the request of the European Commission in order to assess potential risks for patients deriving from the presence of NDMA.

The EDQM is presently working with the EMA, national competent authorities and international partners to understand the issue and will take any necessary actions to protect patients.

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