Official announcements
CHMP Monthly News
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07/07/2022
Up-to-date information from the 20.06-23.06.2022 meeting on new approvals, extensions of indication, newly published EPARs and recently started procedures.
CHMP Monthly News
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07/07/2022
Up-to-date information from the 16.05-19.05.2022 meeting on new approvals, extensions of indication, newly published EPARs and recently started procedures.
messages in brief
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30/06/2022
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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28/06/2022
The Federal Office for Safety in Health Care has been informed by the Danish authority that
informed by the Danish tissue bank European Sperm Bank (DK257572) that a pathogenic variant in the
pathogenic variant in the PHA gene has been identified in sperm donor 27019-NIMBUS and that he is a carrier of
of phenylketonuria (PKU).
Safety warnings
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Blood & Tissue
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28/06/2022
The Federal Office for Safety in Health Care has been informed by the Danish authority that
has been informed by the Danish tissue bank European Sperm Bank (DK257572) that there has been a
in connection with the use of semen from the sperm donor 8481-RAVN in a child for the
Alpha-1 antitrypsin deficiency (AATD) has occurred.
Safety warnings
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Blood & Tissue
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28/06/2022
The Federal Office for Safety in Health Care has been informed by the Danish authority that
the Danish tissue bank European Sperm Bank (DK257572) that the sperm donor 8338-REMON has been diagnosed with
sperm donor 8338-REMON has been diagnosed with Bipolar Disorder Type II.
Recall
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Medicines
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27/06/2022
Precautionary recall due to possible contamination
Recall
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Medicines
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13/06/2022
Recall due to nitrosamine contamination above the permitted daily dose.
Recall
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Medicines
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10/06/2022
Precautionary recall due to possible microbial contamination.