EMA's CHMP recommends indication extensions for Bexsero and Talzenna
PFE•The EMA's CHMP recommended extensions of indication for Bexsero and Talzenna. It also recommended extending Gazyvaro's use for adults with moderate-to-severe active systemic lupus erythematosus and granting marketing authorisation for Baxfendy.
1. CHMP recommendations
The EMA's Committee for Medicinal Products for Human Use recommended extensions of indication for Bexsero, Talzenna and seven other medicines: Cosentyx, Dovato, Enflonsia, Steglatro, Sunlenca, Tivicay and Welireg. It also recommended extending Gazyvaro's use to treat adults with moderate-to-severe active systemic lupus erythematosus and granting marketing authorisation for Baxfendy.
2. Mounjaro contraception notice
The committee adopted a direct healthcare professional communication about the potential effect of Mounjaro on the reliability of oral contraceptives. It reminded healthcare professionals that contraception is recommended for women who can become pregnant and are using Mounjaro.
