"Valsartan/HCT ratiopharm 80 mg/12.5 mg Film-Coated Tablets" and "Valsartan/HCT ratiopharm 160 mg/25 mg Film-Coated Tablets" (active ingredient: valsartan) have been approved for the treatment of hypertension since August 16, 2013. In the course of…

The marketing authorization holder has informed its supplied customers in a letter dated November 16, 2018, that isolated impurities or contamination of the film-coated tablets have been detected, which occurred during the packaging of the…

To summarize legal provisions, requirements regarding content as well as information how to submit and handle Mock-Ups a new Guidance Document was set up, which can be found under…

The marketing authorization holder has informed its supplied customers in a letter dated 13.11.2018 that the above batch is being recalled as a precautionary measure due to a reduced active ingredient content.

Richter Pharma AG" as distributor of the veterinary medicinal product "Doxapram-V", which is approved in Germany, has informed its customers that the batches 1216836AA and 1216836AB are recalled by the marketing authorization holder "Albrecht GmbH".…

The marketing authorization holder has informed its supplied customers by letter dated Nov. 12, 2018, that due to a slightly increased exceedance of the specification for known impurities, the above batch is being recalled.

No acute danger, recall purely as a precautionary measure

Situation in Austria: The Federal Office for Safety in Health Care has received information that several packages of the drug Jakavi 15 mg tablets, for which there is an urgent suspicion of counterfeiting, have entered the legal distribution chain as…

The Federal Office for Safety in Health Care has been informed by the Italian authority that (in addition to the regions already announced) in Barletta-Andria-Trani (Apulia Region), due to the detection of WNV NAT positive horses, ID WNV NAT testing has been introduced for donors of blood and blood components.

The Federal Office for Public Health Safety has been notified by the Spanish authority that two human autochthonous cases of dengue virus infection have occurred in Spain.