Official announcements
CHMP Monthly News
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14/04/2023
Up-to-date information from the November 23.01.-26.01.2023 meeting on new approvals, extensions of indication, newly published EPARs and recently started procedures.
CHMP Monthly News
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14/04/2023
Up-to-date information from the November 20.02.-23.02.2023 meeting on new approvals, extensions of indication, newly published EPARs and recently started procedures.
CHMP Monthly News
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12/04/2023
Up-to-date information from the November 27.03.-30.03.2023 meeting on new approvals, extensions of indication, newly published EPARs and recently started procedures.
messages in brief
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31/03/2023
This issue of RMS NEWS again contains current and relevant news for our applicants for marketing authorisations with Austria as RMS.
Recall
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Medicines
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30/03/2023
Recall due to possible contamination with metal particles
Recall
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Medicines
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16/03/2023
Recall due to incorrect name on the bottle label
Recall
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Blood & Tissue
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13/03/2023
The Federal Office for Safety in Health Care has been informed via the Maltese authority that a recall of Gynemed GmbH&Co KG products (Denu tips and aspiration needles for oocyte puncture) has occurred due to insufficient documentation of testing and control of raw material.
Enforcement
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09/03/2023
The BASG warns against the product "Crusader Savon Médicinal" due to the classification as an illegal medicinal product by presentation.
Recall
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Blood & Tissue
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16/02/2023
The Federal Office for Safety in Health Care has been notified by the Netherlands Authority that sterility issues have occurred with Medtronic's Grafton DBM products (demineralized bone allografts).