From their meeting in April, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights. During the meeting the CHMP announced recommendations for thirteen medicines for approval.
A marketing authorisation was recommended for Sixmo (buprenorphine) as a substitution treatment for opioid dependence. The Sixmo implant releases low levels of buprenorphine into the patient’s body for six months. Two orphan medicines named Esperoct (turoctocog alfa pegol) and Ultomiris (ravulizumab) received positive opinion from the CHMP.
The CHMP gave a positive opinion for an informed consent application for Temybric (fluticasone furoate/umeclidinium/vilanterol) for the maintenance treatment of adult patients with moderate to severe chronic obstructive pulmonary disease. An informed consent application uses data from the dossier of a previously authorised medicine, with the marketing authorisation holder of that medicine giving consent for the use of their data in the application.
After a European Union (EU) safety review concluded on strict legally binding limits for nitrosamine impurities in sartan blood pressure medicines, the EMA are continuing their work with national authorities and international partners to help ensure manufactures are taking the appropriate actions to avoid or keep the presence of nitrosamine below the acceptable limits.
For the meeting summary, and a full list of approvals, opinions and withdrawals, please click here.