What's new
Newsletters "UptoDate" of BASG/AGES MEA are published monthly and contain the latest articles from the last month (link to subscription page).
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Safety warnings
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Blood & Tissue
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12/09/2024
The Federal Office for Safety in Health Care (BASG) has been informed by the Italian authorities that in Italy, in addition to the provinces already announced, the ID WNV NAT test for donations of blood and blood components has been introduced in Vercelli (Piedmont region).
12/09/2024
Dem Bundesamt für Sicherheit im Gesundheitswesen (BASG) wurde von der italienischen Behörde mitgeteilt, dass in Italien, zusätzlich zu den bereits bekannt gegebenen Provinzen, in Vercelli (Region Piedmont), die ID WNV NAT Testung für Spenden von Blut und Blutkomponenten eingeführt wurde.
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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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11/09/2024
The Federal Office for Safety in Health Care has been informed by the Romanian authorities that, in addition to the regions already announced, confirmed human WNV infections have been recorded in Bihor in Romania.
Safety warnings
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Blood & Tissue
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11/09/2024
The Federal Office for Safety in Health Care has been informed by the Slovakian authorities that the ID WNV NAT test for blood and blood component donations has been introduced in Nové Zámky (Nitra region) in Slovakia.
11/09/2024
Quality Management New The quality system of the Austrian federal Office for Safety in Health Care is operated by the Austrian Medicines and Medical Devices Agency and implements the requirements of I
11/09/2024
Dem Bundesamt für Sicherheit im Gesundheitswesen wurde von der slowakischen Behörde mitgeteilt, dass in der Slowakei, in Nové Zámky (Region Nitra) die ID WNV NAT Testung für Spenden von Blut und Blutkomponenten eingeführt wurde.
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11/09/2024
Dem Bundesamt für Sicherheit im Gesundheitswesen wurde von der rumänischen Behörde mitgeteilt, dass in Rumänien, zusätzlich zu den bereits bekannt gegebenen Regionen, in Bihor bestätigte humane WNV-Infektionen verzeichnet wurden.
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GMP/ GDP New
10/09/2024
GMP/ GDP Processing status Electronic submission Organisation Management Service (OMS) - Integration in EudraGMDP Information on inspection preparation Good Manufacturing Practice (GMP) refers to the