CHMP and CMDh News – July 2014
CHMP recommended granting a marketing authorisation of five new medicines
The CHMP recommended granting a marketing authorisation of five new medicines by endorsing the following recommendations:
- for Imbruvica (ibrutinib) and Zydelig (idelalizib), the CHMP recommended granting a marketing authorisation for the treatment of malignant blood diseases;
- for Xultophy (insulin degludec/liraglutid) for the treatment of diabetes mellitus;
- for biosimilar medicine Accofil (filgrastim) for the treatment of neutropenia;
- for the generic medicine Busulfan Fresenius Kabi (busulfan) for the treatment of conditioning before conventional transplantation of haematopoietic progenitor cells.
Seven recommendations for extension of therapeutic indications
The CHMP endorsed recommendations for extension of therapeutic indications for the following medicinal products: Baraclude, Busilvex, Ecalta, Humira, Ozurdex, RoActemra and Xgeva.
The CHMP concluded the review of medicines for emergency contraception
The CHMP concluded the review of medicines for emergency contraception containing levonorgestrel or ulipristal as active substances. The review of these medicines was initiated due to suspected reduction of effectiveness in women with higher bodyweight, observed in certain clinical trials. However, the CHMP having reviewed all the available data on the effectiveness of emergency contraceptives concluded that the available data are not robust enough to draw such conclusions and that these medicines remain an adequate choice for emergency contraception, regardless of the body mass of the woman using the medicine.
More about the review of the medicines for emergency contraception may be viewed on the HALMED and EMA’s webpages.
Other news from the CHMP meeting in July 2014
The application for granting the marketing authorisation for Neofordex was withdrawn.
The agenda and the minutes from the meeting are accessible on the EMA’s webpages.
More about the CHMP meeting held in July 2014, you may find on the EMA’s webpages, or here.
CMDh confirmed the recommendation for suspension of methadone oral solutions containing high molecular weight povidone
The CMDh endorsed by consensus on its meeting held in July 2014 the PRAC’s recommendation to suspend the marketing authorisation of methadone oral solutions containing high molecular weight povidone. These products will remain suspended until they have been reformulated. Additionally, the CMDh agreed that methadone tablets that contain low molecular wight povidone should remain on the market with changes to the product information.
You may view more about the review of methadone forms containing povidone on the EMA’s webpages.