The marketing authorization holder and the distributor have informed their supplied customers by letter dated 28.11.2018 that due to a malfunction in a production facility sterility cannot be guaranteed. Therefore, the above mentioned batch is recalled.

On November 27, 2018 a big "round table" took place on the topic of availability of medicines in Austria. At the top-class event, which was organised by the Federal Office for Safety in Health Care (BASG), more than 30 representatives of the Austrian pharmaceutical stakeholders discussed possible solutions to maintain, secure and further strengthen…

The WHO-National Control Laboratory Network for Biologicals was established to facilitate the availability of WHO pre-qualified vaccines. The WHO pre-qualification programme provides independent opinion/advice on the quality, safety and efficacy of vaccines to qualify for purchase by other UN organisations (eg. UNICEF). The Austrian Control…

The marketing authorization holder informed its supplied customers in a letter dated November 23, 2018, that the active ingredient manufacturer Mylan Laboratory Limited in India has detected the production-related impurity N-nitrosodiethylamine (NDEA) in the active ingredient valsartan. Therefore, the batches of "Valsartan/HCT ratiopharm 80 mg/12.5…

Recall of certain lots of "Valsartan/HCT ratiopharm 80 mg/12.5 mg Film-Coated Tablets" and "Valsartan/HCT ratiopharm 160 mg/25 mg Film-Coated Tablets" containing valsartan active ingredient manufactured by "Mylan Laboratory Limited".

"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 further sartan reviews (a specific class of blood pressure medication), an impurity with…

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 film-coated tablets into the blisters. The batch AV069 is therefore recalled as a precautionary measure.

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 https://www.basg.gv.at/en/medicines/faqs-about-medicinal-products/mock-ups/ (currently only available in German).

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 reason is a reduced content of the preservative chlorobutanol. "Doxapram-V" is a veterinary…