The Federal Office for Safety in Health Care was informed by the Danish authority that it was informed by the Danish tissue bank Cryos International (DK257551) about the disease of a child conceived with the semen of the sperm donor MITTO. In the report of the disease, a 5-year-old child was diagnosed with autism.

In the past, "Poppers" have been defined as functional drugs by the Federal Office for Safety in Health Care (BASG). This classification was also confirmed in 2014 by a ruling of the Administrative Court (see below), whereby the provisions of the Medicines Act applied to the marketing of "Poppers". By a later decision of the European Court of Justice (ECJ, see below) from the same year, the classification of "Poppers" as functional drugs was revoked and is therefore no longer applicable.

The marketing authorization holder informed its supplied customers in a letter dated December 3, 2018, that there are increased reports of side effects for the two batches 180619 and 180620, which refer to "severe burning sensation in the eye". The…

The marketing authorization holder has informed its supplied customers in a letter dated 28.11.2018 that sterility cannot be guaranteed due to an identified problem at the manufacturer. Therefore, the above mentioned batch is recalled.

Action at EU level The European Medicines Agency (EMA) has scientifically reassessed the serious, disabling and potentially permanent side effects of quinolone and fluoroquinolone antibiotics taken orally, injected or inhaled. This assessment also…

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…

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…

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…

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…

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".