Official announcements
messages in brief
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11/05/2017
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…
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04/05/2017
The Austrian Health Portal, operated by GÖG, has a new service for physicians:
"Drug Safety Information Platform".
Recall
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Medicines
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28/04/2017
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…
Safety warnings
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messages in brief
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12/04/2017
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…
Safety warnings
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Medicines
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12/04/2017
Meda Pharma GmbH expands recall of EpiPen auto-injectors to include additional lots
Recall
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Medicines
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12/04/2017
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.…
Recall
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Medicines
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07/04/2017
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…
Enforcement
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06/04/2017
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.
Enforcement
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06/04/2017
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.
messages in brief
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29/03/2017
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…