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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 July 2014

London (July 25, 2014) – 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 on the website 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The application for a marketing authorisation for Neofordex has been withdrawn.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 on the website.

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.

CHMP statistics

Key figures from the July 2014 CHMP meeting are represented in the graphic at the link below.

For an overview of all information available from the July CHMP, please click on the below link:

• http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2014/07/news_detail_002142.jsp&mid=WC0b01ac058004d5c1  

European Medicines Agency (EMA), 25.07.2014 (tB).