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.…

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…

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 “legislational freedom” often results in national legal differences, as for example the so-called “Eigenherstellung” or “Individual small scale contract production” of medicinal products by physicians. Which is not allowed in Austria but licit in some states of the European Union like the Federal Republic of Germany.

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 especially various cancers.

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…

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,…

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…

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…