The Federal Office for Safety in Health Care has been informed by the Danish authority that it has been informed by the Danish tissue bank Cryos International ApS (DK257551) about the disease of a child conceived with the semen of sperm donor 6932. The report of the disease describes a child with developmental delay. Genetic testing by aCGH (array…

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 ApS (DK257551) about the disease of a child conceived with the semen of sperm donor 3614. The report of the condition described a 6-year-old child diagnosed with Asperger syndrome with signs of…

The marketing authorization holder informed its supplied customers in a letter dated January 23, 2018, that "Saroten 10mg Film-Coated Tablets" was placed on the market with an incorrect dosage information for the treatment of depressive disorders (episodes of major depression) in the package leaflet. Therefore, the two batches placed on the market…

The 2016/2017 yellow fever outbreak in Brazil was declared over in September 2017. The upsurge of human cases since December 2017 and non-human primate epizootics since September 2017 indicates a resurgence of the circulation of yellow fever virus in Brazil, and more particularly in São Paulo State.

AGES MEA experts are continuously working on the third revision of the international guideline ICH S5(R2) "Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility", which has now been made available for public comment for the first time (CPMP/ICH/386/95). For a long time, as a result of the bitter experience with…

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 ApS (DK257551) about the disease of a child conceived with the semen of sperm donor 5971.

AGES MEA experts took the rapporteur role for the development of the new EMA document: "Reflection Paper on statistical methodology for the comparative assessment of quality attributes in drug development" (EMA/CHMP/138502/2017). Over the past 2.5 years, experts from AGES Medical Market Surveillance have been involved in the development of a new…

The marketing authorization holder informed its supplied customers in a letter dated 27.11.2017 that the stability test did not comply with the test for gastric juice resistance. The potential impact on patient safety is assessed as low. All other batches available in Austria are not affected by this recall.

The distribution partner for the marketing authorization holder, "DSD Pharma GmbH", informed its supplied customers in a letter dated November 15, 2017, that the qualified person for batch 171115FDG01 has not issued a batch release and that the batch in question may therefore not be used.

The marketing authorization holder has informed its supplied customers in a letter dated 22.11.2017 that deviations from the microbial limit values were detected in a batch marketed abroad. As a precautionary measure, all batches that were produced within a short time of this are now being recalled. In Austria, this concerns batch T12052 of the…