Official announcements
messages in brief
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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
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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
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20/04/2020
Central contact points in each federal state survey needs and coordinate distribution
messages in brief
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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.
Safety warnings
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Blood & Tissue
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14/04/2020
Only available in German
Recall
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Medicines
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08/04/2020
Recall due to colourless, instead of milky white emulsion
messages in brief
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02/04/2020
Chloroquin und Hydroxychloroquin dürfen gegen Corona-Virus nur in klinischen Studien oder Notfallprogrammen verwendet werden
messages in brief
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29/03/2020
The regulation on ensuring the supply of medicinal products enters into force as from April 1, 2020, and comprises any restriction in supply of prescription-only human medicines.
messages in brief
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27/03/2020
Keine Hinweise die Zusammenhang zwischen ACE-Hemmern oder ARBs und Verschlechterung von Coronaerkrankung belegen, daher Therapie nicht abbrechen/umstellen
messages in brief
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26/03/2020
Based on the current situation it has been agreed between the EMA and NCAs to extent the deadline for submission to complete Step 1 for the evaluation of the risk of the presence of nitrosamine impurities in human medicinal products containing chemically synthesised active pharmaceutical ingredients, from 26. March 2020 to 1. October 2020.