Official announcements
messages in brief
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30/09/2021
This issue of RMS NEWS again contains current and relevant news for our applicants for marketing authorisations with Austria as RMS.
Enforcement
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28/09/2021
Distribution of an unauthorised medicinal product through illegal websites
Recall
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Medicines
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27/09/2021
Recall of batches with nitrosamine levels above the acceptable daily limit.
Recall
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Medicines
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21/09/2021
Recall due to azido contamination above the acceptable limit.
Recall
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Medicines
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21/09/2021
Recall due to azido contamination above the acceptable limit.
messages in brief
Medicines
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20/09/2021
The Product Information has been updated with the new shelf-life for the frozen vial, that has been extended from 6 months to 9 months. The storage conditions remain unchanged (-90 °C to -60 °C).
Safety warnings
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Blood & Tissue
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20/09/2021
The Federal Office for Safety in Health Care has been informed by the ECDC (European Centre for Disease Prevention and Control) that a human WNV infection has been reported for the first time in the Spree-Neiße region in Germany during the current season.
Recall
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Veterinary Medicines
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09/09/2021
Recall following a Commission Decision concerning veterinary medicinal products for injection containing vitamin A as active substance
Safety warnings
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Blood & Tissue
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07/09/2021
The Federal Office for Public Health Safety has been notified by the ECDC (European Centre for Disease Prevention and Control) that another human WNV infection has been recorded in Hungary.