Novo Nordisk Gets Positive CHMP Opinion for Extended Insulin Use
Novo Nordisk has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency to extend the use of NovoRapid (insulin aspart) in the European Union for children with diabetes from as young as one year old.
The positive CHMP opinion will be sent to the European Commission for final regulatory decision, expected within two months.
NovoRapid is a mealtime insulin analogue indicated for diabetes mellitus in adults, adolescents, and children aged two years old and above. NovoRapid has been available for use in Europe since 1999 and has been launched in more than 120 countries.
Source: Novo Nordisk