On 9 November 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Adynovi, intended for the treatment and prophylaxis of bleeding in patients 12 years and above with haemophilia A (congenital factor VIII deficiency). The drug will be available as a powder and solvent for solution for injection (250 IU, 500 IU, 1000 IU and 2000 IU). The active substance of Adynovi is rurioctocog alfa pegol, a recombinant human factor VIII which replaces the missing coagulation factor VIII needed for effective haemostasis (ATC code: B02BD02). The benefits with rurioctocog alfa pegol are its ability to prevent and control bleeding when used on demand and during surgical procedures, as seen in clinical trials in adult and paediatric patients with haemophilia A. The most common side effects are headache, diarrhoea, nausea and rash. The full indication is: “treatment and prophylaxis of bleeding in patients 12 years and above with haemophilia A (congenital factor VIII deficiency)”. If approved, the adults and adolescent patients having hemophilia A in Europe will get a new treatment option with a twice-weekly prophylaxis dosing schedule. This will help the patients to manage their hemophilia A care with their physicians in the way that works best for them.