EMA: Suspension of ranitidine medicines
As the EMA announced on 30 April 2020, all ranitidine medicines in the EU are to be taken off the market.
The acid blockers are suspected of being carcinogenic due to contamination with N-nitrosodimethylamines (NDMA) in unacceptable amounts. The study situation is still uncertain, but it is assumed that the NDMA content increases with increasing storage time of the medicines. It is unclear whether NDMA is also formed within the body after taking the medicine.
Many ranitidine medicines have not been available in the EU for several months, as they have already been recalled by national authorities. The EMA reserves the right to lift the suspension under certain conditions. Among other things, the manufacturers are requested to provide more data. For the same reasons, the US FDA had already requested the withdrawal of ranitidine from the market on April 1, 2020.
Quelle:
EMA: Press release: Suspension of ranitidine medicines in the EU
Meet the GMP Compliance Adviser
The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business.
The demo access is non-binding and ends automatically.
You may also be Interested in the Following Articles:
