Official announcements
CHMP Monthly News
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30/11/2022
Up-to-date information from the 10.10.-13.10.2022 meeting on new approvals, extensions of indication, newly published EPARs and recently started procedures.
CHMP Monthly News
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30/11/2022
Up-to-date information from the 12.09-15.09.2022 meeting on new approvals, extensions of indication, newly published EPARs and recently started procedures.
Recall
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Medicines
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21/11/2022
Recall due to yellowish discolouration of the solution
messages in brief
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17/11/2022
i-SPOC registration has been mandatory since September 2, 2022 and applies to all pharmaceutical companies with a centrally- or nationally-authorised human medicinal product in the EU.
Recall
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Medicines
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17/11/2022
Batch recall due to possible product mix
messages in brief
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07/11/2022
Drug authorities around the world are reminding people of the importance of reporting suspected adverse drug reactions in a joint campaign called MedSafetyWeek.
Recall
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Medicines
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07/10/2022
Recall due to incorrect information on the blister foil
messages in brief
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30/09/2022
This issue of RMS NEWS again contains current and relevant news for our applicants for marketing authorisations with Austria as RMS.