Posted by Michael Wonder on 15 Nov 2021
Ozempic 2 mg recommended for approval for the treatment of type 2 diabetes by the European Medicines Agency
12 November 2021 - Novo Nordisk today announced that the EMA's CHMP has adopted a positive opinion recommending a label extension for the existing marketing authorisation for Ozempic to introduce a new dose of 2 mg.
Ozempic is currently approved in the EU in 0.5 mg and 1.0 mg doses for the treatment of type 2 diabetes in adults.
The positive opinion is based on the results from the SUSTAIN FORTE trial.
