EMA launches survey for patients and healthcare professionals on knowledge of reporting adverse reactions - Federal Office for Safety in Health Care (BASG) recommends participation The European Medicines Agency (EMA) has launched a -> Survey survey to better understand the awareness and willingness of both patients and healthcare professionals to…

"AOP Orphan Pharmaceuticals AG" informed its supplied customers by letter dated August 31, 2017, that "Thromboreductin 1.0 mg Capsules" was placed on the market as a medicinal product not authorized in Austria in this strength with defective packaging, since the labeling and directions for use were not approved by the BASG.

The medicinal product "Melphalan Koanaa 50 mg i.v. powder and solvent for the preparation of a solution for injection or infusion" (active substance Melphalan) does not have a valid marketing authorization in Austria, but was placed on the market by the company "Koanaa Healthcare GmbH", Fehrgasse 7, 2401 Fischamend, with an apparently Austrian…

The drug "Melphalan Koanaa 50 mg i.v. Powder and Solvent for Solution for Injection or Solution for Infusion" is being recalled due to suspected drug counterfeiting.

The marketing authorization holder has informed its supplied customers in a letter dated August 10, 2017, that a batch of Vibravenous - Ampoules with batch number B113306 is being recalled due to distinct color changes.

"Koanaa Healthcare GmbH" has informed its customers in a letter dated August 10, 2017, that the further marketing of "Melphalan Koanaa 50 mg i.v. Powder and Solvent for Solution for Injection or Solution for Infusion" will be stopped and a recall will be carried out.On the part of the Federal Office for Safety in Health Care (BASG), there is an…

"Pascoe Pharm. Präparate GmbH" as the holder of the registration as a homeopathic medicinal speciality of "Quassia Similiaplex drops" has informed its supplied customers by letter dated 26.07.2017 that the registration will be cancelled as of 01.09.2017. The medicinal speciality will be marketed as a new registration from this date. To ensure that…

The marketing authorization holder has informed its supplied customers in a letter dated July 25, 2017, that a test result within the scope of a stability study showed a reduced active ingredient content. Therefore, the batch 559CG placed on the market in Austria, which is related to this stability study, is recalled from the market.

NovoPen Echo and NovoPen 5 are used for insulin therapy in people with diabetes. It has been noted that the insulin cartridge holder may tear or break in certain lots of NovoPen Echo and NovoPen 5 insulin pens. Using a pen with a torn/broken cartridge holder may result in a lower insulin dose being delivered than intended. This may result in a rise…

The marketing authorization holder has informed its supplied customers in a letter dated July 04, 2017, that individual bottles filled with distilled water were included in the packaging of Buerlecithin liquid 500 ml. For this reason, this batch is recalled. There is no risk to patient safety.