In September 2019, the European Commission (EC) requested EMA to start a review of ranitidine medicines after tests showed that some of these products contained the impurity N-nitrosodimethylamine (NDMA). Ranitidine medicines are used widely to reduce the production of stomach acid in patients with conditions such as heartburn and stomach ulcers.
According to the ongoing assessment, the rapporteurs of the ranitidine referral consider that the benefit-risk balance of medicinal products containing ranitidine cannot be concluded as being positive and proposed to suspend all marketing authorisations with conditions to lift the suspension.
In the meantime, FDA has requested to all marketing authorisation holders (MAHs) to withdraw the marketing authorisations in US and ranitidine will no longer be available in US as OTC nor Rx prescriptions.
If you need any help, please contact us at info@asphalion.com
The research team observed changes in head circumf...
AtCDF3 gene induced greater production of sugars a...
Un estudio con datos de los últimos 35 años, ind...
En nuestro post hablamos sobre este interesante tipo de célula del...
Investigadores del Cima Universidad de Navarra constatan que la combin...
