08.01.2021 - Notice within the graduated plan procedure (“Stufenplanverfahren”)

Temporary suspension of marketing authorisations for medicinal products

The Federal Institute for Drugs and Medical Devices (BfArM) has ordered the temporary suspension of all holders of marketing authorisations for medicinal products containing ranitidine.

29.09.2020 - National implementation

The pharmaceutical contractors, to whom the national graduated plan notification will be addressed, are requested to notify due changes with the functional structure number (SKNR) 6523 (keyword "Ranitidine referral").

18.09.2020 - Renewed opinionof the CHMP

EMA’s human medicines committee (CHMP) has confirmed its recommendation to suspend all ranitidine medicines in the EU due to the presence of low levels of an impurity called N-nitrosodimethylamine (NDMA). This follows a re-examination of CHMP’s April 2020 opinion, which was requested by one of the companies marketing ranitidine medicines.

05.05.2020 - CHMP opinion

Suspension of ranitidine medicines in the EU

EMA’s human medicines committee (CHMP) has recommended the suspension of all ranitidine medicines in the EU due to the presence of low levels of an impurity called N-nitrosodimethylamine (NDMA).

17.09.2019 - Procedure started

At the request of the European Commission, the European Medicines Agency (EMEA) has launched a review of ranitidine-containing medicines after tests have shown that some of these products contain the impurity N-nitrosodimethylamine (NDMA).

Further information

For details on the procedure please click on the following link to the homepage of the European Medicines Agency (EMA):