Official announcements
Recall
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Medicines
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23/12/2021
Recall of two batches due to a deviation of the active substance content diphenhydramine
Recall
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Medicines
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22/12/2021
Recall due to azido contamination above the acceptable limit.
Safety warnings
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Blood & Tissue
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21/12/2021
The Federal Office for Safety in Health Care has been informed by the Danish authority that it has been informed by the Danish tissue bank European Sperm Bank (DK257572) that a POLG-associated disease of a child has occurred in connection with the use of semen from the sperm donor 8948-ERHAN.
messages in brief
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16/12/2021
An overview of information by BASG to the novel Corona virus SARS-CoV-2 and the COVID-19 disease as well as links to websites with further information.
CHMP Monthly News
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15/12/2021
Up-to-date information from the 08.11.-11.11.2021 meeting on new approvals, extensions of indication, newly published EPARs and recently started procedures.
Recall
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Medicines
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14/12/2021
Recall due to particles.
Recall
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Veterinary Medicines
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06/12/2021
Recall due to visible particles in solution for injection.
messages in brief
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24/11/2021
Representatives of PEI and AGES-MEA again discussed national legal requirements and cooperation on allergens.
messages in brief
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17/11/2021
The new legal framework for veterinary medicines (Regulation 2019/6 and 2021/16, Article 9(h)) requires the following changes to the EudraGMDP database, which will be implemented from 28 January 2022.
Safety warnings
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Blood & Tissue
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15/11/2021
The Federal Office for Safety in Health Care has been informed by the Danish authority that it has been informed by the Danish tissue bank Cryos International (DK257551) that Alport syndrome has been confirmed as a dominant heritable genetic cause in the donor BLOB family.