This page provides an overview of the opinions adopted at the July 2014 meeting of the Committee for Medicinal Products for Human Use (CHMP) and other important outcomes.
Five new medicines recommended for approval
The CHMP has recommended granting marketing authorisations for two new medicines for the treatment of various rare cancers of the blood, Imbruvica (ibrutinib) and Zydelig (idelalisib). Please see the press release in the grid below for more information.
Granting a marketing authorisation to Xultophy (insulin degludec/liraglutide) for the treatment of diabetes mellitus has also been recommended.
The CHMP recommended granting a marketing authorisation for Accofil (filgrastim), a biosimilar medicine intended for the treatment of neutropenia.
The generic medicine Busulfan Fresenius Kabi (busulfan) was also recommended for authorisation for conditioning treatment prior to conventional haematopoietic progenitor cell transplantation.
Seven recommendations on extensions of therapeutic indications
The Committee recommended extensions of indications for Baraclude, Busilvex,Ecalta, Humira, Ozurdex, RoActemra and Xgeva.
Outcome of review on emergency contraceptives
The CHMP has concluded its review of emergency contraceptives containing levonorgestrel and ulipristal acetate.
Withdrawal of application
The application for a marketing authorisation for Neofordex has been withdrawn. For more information, please see question-and-answer document in the grid below.
Agenda and minutes
The agenda of the July 2014 meeting is published on the EMA website. The minutes of the meeting will be published during the week following the next meeting of the CHMP which will take place from 22-25 September 2014. Minutes of the June 2014 CHMP meeting will be published next week.
Posted on the EMA website on 25 July 2014