The approval comes after Novartis proposed changes to the EU label recommending that liver monitoring should be conducted at the start of treatment, every three months for the first year, and periodically thereafter. The Eucreas approval closely follows European approval of the updated label for Galvus announced earlier this month.
The decision applies in all 27 countries of the EU as well as in Norway and Iceland, and both medicines will be available in the first European countries within the next few weeks... Novartis' Press Release -