Europe’s CHMP confirms ranitidine suspension

Europe’s CHMP confirms ranitidine suspension

21 September 2020 - Deborah Wilkes

Europe’s Committee for Medicinal Products for Human Use (CHMP) has confirmed its recommendation that all medicines containing ranitidine should be suspended in the European Union.

The CHMP re-examined its recommendation following a request from a company marketing ranitidine medicines (click here to read the News story).

Announcing the suspension in April 2020, the European Medicines Agency (EMA) said the move was a “precaution” due to the presence of low levels of an impurity called N-nitrosodimethylamine (NDMA), which is a probable human carcinogen (click here to read the News story).

Follows action in the US

The suspension was announced just one month after the US Food and Drug Administration (FDA) asked manufacturers to withdraw all prescription and OTC medicines containing ranitidine from the market immediately (click here to read the News story).

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