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…

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that due to the global decision of the company, the marketing authorization of the medicinal product "Trobalt" will be withdrawn in all strengths. Therefore, a recall will be carried out at wholesalers and pharmacies from 01.07.2017.

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 2016, the total number of adverse reaction reports (initial and follow-up reports) increased by +13%…

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 EMA Management Board has now given the green light for the changeover to "central reporting" as…

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 batch 16LC6994 is being recalled.

The new guide summarizes rules and recommendations related to designations and names of human and veterinary drug specialties and is intended to assist applicants in finding appropriate designations and names. More information: AT Guide to the Designation of Proprietary Medicinal Products.

The Austrian Health Portal, operated by GÖG, has a new service for physicians: "Drug Safety Information Platform".

The marketing authorization holder has informed its supplied customers in a letter dated April 27, 2017, that the affected batches are being recalled due to a possible minor contamination with ethylene glycol. According to current knowledge, the occurrence of side effects due to the contamination for patients is unlikely.

EpiPen 300 microgram solution for injection in a ready-to-use pen (epinephrine) and EpiPen Junior 150 microgram solution for injection in a ready-to-use pen (epinephrine) have been approved under the MRP/DCP procedure since March 30, 1998 for the emergency treatment of severe allergic reactions (anaphylaxis) to e.g. insect stings or bites, food,…