Official announcements
Safety warnings
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Blood & Tissue
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22/11/2024
The Federal Office for Safety in Health Care has been informed by the Greek authorities that in Greece, in addition to the regions already announced, a confirmed human WNV infection has been recorded in Zografos.
Safety warnings
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Medical devices
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22/11/2024
The Federal Office for Safety in Health Care (BASG) warns against a potential Contamination of non-sterile ultrasound gel „AquaUltra Clear“ of the manufacturer Ultragel Medical Kft. According to the manufacturer the affected LOT has been narrowed down to LOT-Number 2024-4 to 2024-10.
Safety warnings
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Blood & Tissue
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22/11/2024
The Federal Office for Safety in Health Care (BASG) has been informed by the French authorities that a confirmed autochthonous case of chikungunya has been recorded in La Réunion (overseas department; town: Etang Salé).
messages in brief
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19/11/2024
The BASG reminds marketing authorization holders/registration holders that submissions by a third party (e.g. a consultant) are only valid with the appropriate authorization.
Safety warnings
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Blood & Tissue
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18/11/2024
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 Turkey in Antalya, Hatay, Kırklareli and Muğla, in addition to the regions already announced.
Safety warnings
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Blood & Tissue
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18/11/2024
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 Toledo.
Safety warnings
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Blood & Tissue
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18/11/2024
The Federal Office for Safety in Health Care has been informed by the ECDC (European Centre for Disease Prevention and Control) that in Germany, in addition to the regions already announced, confirmed human WNV infections have been recorded in Spree-Neiße.
Romefen PR 10% New
Recall
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Veterinary Medicines
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15/11/2024
Recall due to delivery of an incorrect batch in Austria
CHMP Monthly News
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14/11/2024
Up-to-date information from the 14.10.-17.10.2024 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.
Recall
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Medicines
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11/11/2024
Recall due to incorrect information in the patient information leaflet