Official announcements
Recall
|
Medicines
|
13/05/2020
Recall due to individual cases of not properly sealed flanges of the aluminium capsule on the vial
Recall
|
Medicines
|
08/05/2020
Recall due to exceeding the specification for related substances
Safety warnings
|
Blood & Tissue
|
30/04/2020
Only available in German
messages in brief
|
30/04/2020
Only available in German
messages in brief
|
24/04/2020
Anwendung soll nur im Rahmen klinischer Studien oder valider Behandlungs-Protokolle stattfinden. Alle Nebenwirkungen sollen gemeldet werden.
messages in brief
|
22/04/2020
Recent information about regulatory flexibility during the corona pandemic can be found here on the website of the BASG.
messages in brief
|
22/04/2020
The EMA adopted the new recommendations for the composition of seasonal influenza vaccines for the season 2020/2021 (published 1 April 2020).
messages in brief
Medicines
|
20/04/2020
Central contact points in each federal state survey needs and coordinate distribution
messages in brief
|
17/04/2020
In the EMA document "Compilation of QRD decisions on stylistic matters in product information" a new, Europe-wide harmonised practice for oral/parenteral medicinal products containing less than 1 mmol sodium per dose was published. In section 2 of the SmPC, there is no need to declare sodium, neither qualitatively nor quantitatively for oral/parenteral medicinal products containing less than 1 mmol sodium per dose. Section 3 of the labelling there is no need to declare sodium for oral medicinal products containing less than 1 mmol of sodium per dose.