Only available in German

Anwendung soll nur im Rahmen klinischer Studien oder valider Behandlungs-Protokolle stattfinden. Alle Nebenwirkungen sollen gemeldet werden.

Recent information about regulatory flexibility during the corona pandemic can be found here on the website of the BASG.

The EMA adopted the new recommendations for the composition of seasonal influenza vaccines for the season 2020/2021 (published 1 April 2020).

Central contact points in each federal state survey needs and coordinate distribution

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.

Chloroquin und Hydroxychloroquin dürfen gegen Corona-Virus nur in klinischen Studien oder Notfallprogrammen verwendet werden

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.

Keine Hinweise die Zusammenhang zwischen ACE-Hemmern oder ARBs und Verschlechterung von Coronaerkrankung belegen, daher Therapie nicht abbrechen/umstellen

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.