Official announcements
Recall
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Medicines
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04/10/2024
Recall due to possible particles in solution
CHMP Monthly News
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01/10/2024
Up-to-date information from the 16.09.-19.09.2024 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.
messages in brief
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30/09/2024
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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Blood & Tissue
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30/09/2024
The Federal Office for Safety in Health Care has been informed by the ECDC (European Centre for Disease Prevention and Control) that confirmed human WNV infections have been recorded in North Macedonia, in addition to the region already announced, in the Southeast region (Jugoistočen).
Safety warnings
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Blood & Tissue
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30/09/2024
The Federal Office for Safety in Health Care has been informed by the ECDC (European Centre for Disease Prevention and Control) that human WNV infections have been recorded in the Czech Republic, in the Jihomoravský kraj region.
Safety warnings
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Blood & Tissue
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23/09/2024
The Federal Office for Safety in Health Care has been informed by the ECDC (European Centre for Disease Prevention and Control) that in Spain, in addition to the regions already announced, confirmed human WNV infections have been recorded in Córdoba, Cáceres and Jaén.
Safety warnings
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16/09/2024
The Federal Office for Safety in Health Care (BASG) has been informed by the ECDC (European Center for Disease Prevention and Control) that confirmed autochthonous human dengue cases have been recorded in the regions of Catalonia (province of Tarragona) and Murcia, as well as in the province of Cadiz and Ibiza.
Safety warnings
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Veterinary Medicines
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11/09/2024
Important information from the Federal Office for Safety in Health Care about the known risk of diabetic ketoacidosis (DKA) in cats with diabetes mellitus associated with the use of Senvelgo 15 mg/ml oral solution for cats (velagliflozin).
Safety warnings
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Blood & Tissue
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05/09/2024
The Federal Office for Safety in Health Care was informed about confirmed autochthonous WNV cases in Vienna and the Weinviertel region.