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,…

Meda Pharma GmbH expands recall of EpiPen auto-injectors to include additional lots

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

European directives relating to medicinal products have to be transposed into national law by the member states. A certain flexibility of this transposition is aimed at the optimal implementation of European requirements into national standards in order to provide for global European interests such as high-quality health care. This relative…

For the past few years informations concerning a substance called “GcMAF” have been circulating the internet. Several online sources denote GcMAF as harmless treatment for diverse illnesses, such as autism, different viral infections (HIV, Hepatitis B and C, influenza, etc.), chronic fatigue syndrome, autoimmune diseases (ALS, MS, etc.) and…

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.