The marketing authorization holder has informed its supplied customers about the extended voluntary recall of additional EpiPen batches in a letter dated April 12, 2017. There is a very low probability that the auto-injector does not work correctly. Worldwide, there were two customer complaints outside of Austria where the pen failed to trigger…

The marketing authorization holder has informed its supplied customers in a letter dated April 6, 2017, that individual bottles filled with 100 ml of distilled water were included in the packaging of Buerlecithin liquid 1000 ml. For this reason, this batch is recalled. There is no risk to patient safety

The International Coalition of Medicines Regulatory Agencies (ICMRA) admitted the Federal Office for Healthcare Safety/AGES Medical Market Surveillance as an associate member on March 20, 2017. ICMRA is a forum composed globally of the heads of a number of regulatory agencies committed to providing strategic leadership worldwide to address current…

EpiPen 300 micrograms solution for injection in a ready-to-use pen (epinephrine) has 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, drugs and other allergens, as well as idiopathic or exercise-induced anaphylaxis. Meda Pharma…

Worldwide, there were two complaints outside of Austria that the auto-injector did not work correctly. Meda Pharma GmbH is therefore recalling a batch of EpiPen 300 micrograms in Austria.

The marketing authorization holder informed its supplied customers in a letter dated March 23, 2017, that there is a very low probability that the auto-injector of batch 5FA665N does not work correctly. Worldwide, there were two customer complaints outside of Austria where the pen could not be triggered during an intended use. Therefore, a…

Swissmedic , the Swiss Agency for Therapeutic Products, wants to work more closely with its partner authority in Austria. Swissmedic Director Jürg H. Schnetzer and Christa Wirthumer-Hoche, Business Unit Head of Medical Market Surveillance at the Austrian Agency for Health and Food Safety GmbH (AGES) signed a Memorandum of Understanding in Vienna,…

Due to current events (see screenshot), the Federal Office for Safety in Health Care points out that according to §59 of the Medicines Act, private individuals are prohibited from offering medicines privately for sale to other persons or from trading with them in general. The offering of medicinal products, in particular via Internet platforms such…

The marketing authorization holder has informed its supplied customers in a letter dated 22.2.2017 that a possible contamination with another active ingredient has been discovered at the manufacturer. For this reason, a recall of the above-mentioned medicinal specialties is being carried out as a precautionary measure. Based on the available data,…

Since toxic pyrrolizidine alkaloids (PAs) were detected in high concentrations in herbal medicinal products produced from plants that do not biosynthesize PAs themselves, in March 2016 BASG published risk-minimizing measures that were to be implemented by all affected marketing authorization / registration holders (<link…