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…

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…

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…

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…

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…

The marketing authorization holder has informed its supplied customers in a letter dated 23.06.2017 that due to the global decision of the company, the marketing authorization of the medicinal product "Trobalt" will be withdrawn in all strengths.…

The spontaneous reporting system for adverse drug reactions is of enormous importance for the early identification of new risks of medicinal products. However, its functioning depends crucially on the cooperation of all healthcare professionals. In…

After the European database EudraVigilance now fulfills all functionalities required by Regulation (EC) No. 726/2004, these have been positively accepted by an independent audit and confirmed by the Pharmacovigilance Risk Assessment Committee (PRAC),…

The marketing authorization holder has informed its supplied customers in a letter dated May 23, 2017, that increased black visible particles have been detected in a batch of "Elotrace - Infusion Additive".Based on these observations, the affected…