Official announcements
CHMP Monthly News
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04/08/2021
Up-to-date information from the 19.07.-22.07.2021 meeting on new approvals, extensions of indication, newly published EPARs and recently started procedures.
Safety warnings
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Blood & Tissue
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02/08/2021
The Federal Office for Safety in Health Care has been informed by the ECDC (European Centre for Disease Prevention and Control) that a human dengue case has occurred in France, in the Var region.
Recall
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Medicines
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30/07/2021
Recall of one batch due to a deviation during stability monitoring analysis.
messages in brief
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19/07/2021
The registry lists in a new form - with search and filter options - those SARS-CoV-2 rapid antigen tests that can be placed on the Austrian market for self-testing.
Recall
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Medicines
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09/07/2021
Recall due to a possible exceedance of the permitted exposure levels for a derivative of the active substance.
messages in brief
CHMP Monthly News
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07/07/2021
Up-to-date information from the 21.06.-24.06.2021 meeting on new approvals, extensions of indication, newly published EPARs and recently started procedures.
Safety warnings
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Blood & Tissue
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01/07/2021
The Federal Office for Safety in Health Care has been informed by the Italian authority that a human WNV case has occurred in the province of La Spezia (Liguria Region). ID WNV NAT testing for donations of blood and blood components has been introduced.
messages in brief
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30/06/2021
This issue of RMS NEWS again contains current and relevant news for our applicants for marketing authorisations with Austria as RMS.
Safety warnings
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Medical devices
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29/06/2021
With this letter, the Federal Office for Safety in Health Care (BASG) draws attention to a possible risk from devices manufactured by Respironics, Inc. (Philips Respironics). The medical devices concerned are ventilators.
Safety warnings
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Medicines
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28/06/2021
Decrease in plasma donations with simultaneous increase in demand for immunoglobulins.