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…
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…
Safety warnings
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messages in brief
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23/03/2017
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,…
Safety warnings
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Medicines
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23/03/2017
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.
