Can I read EMA Guidance on Nitrosamine Impurities on EtoBox?

EMA Guidance on Nitrosamine Impurities by marwaw7h is a document available to read on EtoBox.

What is EMA Guidance on Nitrosamine Impurities about?

The European Medicines Agency has assessed the risk of nitrosamine formation or presence during the manufacture of human medicines. Nitrosamines are classified as probable human carcinogens. The EMA provided guidance to prevent nitrosamine impurities after they were detected in sartan blood pressure medicines in 2018. The EMA finalized a review in 2020 and asks companies to review products for nitrosamines and improve manufacturing as needed. A new oversight group monitors progress on addressing nitrosamine

Author

marwaw7h

Language

EN