Official announcements
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24/05/2017
After the European database EudraVigilance now fulfills all functionalities required by Regulation (EC) No. 726/2004, these have been positively accepted by an independent audit and confirmed by the Pharmacovigilance Risk Assessment Committee (PRAC),…
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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".
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…
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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,…
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16/03/2017
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…
Safety warnings
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messages in brief
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06/03/2017
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…
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21/02/2017
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…
Safety warnings
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messages in brief
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30/01/2017
New recommendations for levonorgestrel emergency contraceptives in case of interactions with CYP3A4-inducing drugs. In Austria, the current recommendations of the European Medicines Agency are being implemented following a technical review of…