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…

The Federal Office for Public Health Safety was informed by the Greek authority that the first human WNV (neuro-invasive disease) infection was confirmed in the Argolida region (Argos-Mycenae and Nafplio).

"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.

An increase in Legionnaires’ disease cases is currently being reported in EU travellers returning from Palmanova in Mallorca, Spain. Eighteen cases, one of which was fatal, have been reported, with dates of onset between 11 September 2017 and 7 October 2017.

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.

Measures at EU level A Europe-wide review of Symbioflor E. coli drops by the European Medicines Agency (EMA) has shown that the drops can continue to be used for the treatment of irritable bowel syndrome (IBS) in adults. However, the medicinal product should no longer be used for the treatment of so-called functional gastrointestinal disorders, as…

The marketing authorization holder has informed its supplied customers in a letter dated June 21, 2017, that in the course of stability tests a trend towards a decrease of the active ingredient "Ambroxol hydrochloride" towards the end of the term has been detected. Therefore, three batches with batch numbers 2015008, 2016002, 2016019, which are…