Seven new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended seven medicines for approval at its September 2020 meeting.
The CHMP adopted a positive opinion for Exparel (bupivacaine), for the treatment of post-operative pain.
The Committee recommended granting marketing authorisations for two vaccines: MenQuadfi (meningococcal group A, C, W and Y conjugate vaccine), for prophylaxis against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W and Y; and Supemtek (Quadrivalent Influenza Vaccine (recombinant, prepared in cell culture)), for prophylaxis against influenza.
The biosimilar medicine Nyvepria (pegfilgrastim) received a positive opinion for reducing the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy…