This page provides an overview of the opinions adopted at the May 2013 meeting of the Committee for Medicinal Products for Human Use (CHMP) and other important outcomes.
Seven new medicines recommended for approval
- The CHMP recommended the approval of Pomalidomide Celgene for the treatment of multiple myeloma. A separate press release on this medicine is included in the table below.
- A new vaccine against smallpox, Imvanex, was recommended for approval for use in the European Union under exceptional circumstances.
- The Committee also recommended the granting of a marketing authorisation for Lonquex, a medicine for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy.
- The CHMP also gave a positive recommendation for the approval of Voncento for the prevention and treatment of bleeding in von Willebrand disease and haemophilia A (congenital FVIII deficiency).
- Lojuxta received a positive opinion from the CHMP for the treatment of homozygous familial hypercholesterolaemia, in addition to a low fat diet and other lipid-lowering medicinal products.
- A new medicine, Somatropin Biopartners, was granted marketing authorisation by the CHMP as a replacement therapy for endogenous growth hormone deficiency.
- The CHMP also recommended that the generic medicine Atosiban Sun should be granted marketing authorisation for the delay of imminent pre-term birth in pregnant adult women.
Four recommendations for extension of indication
The CHMP recommended an extension of the existing indications for Glivec, Lucentis, Prevenar 13 and Tysabri. An application to extend another indication for Tysabri has been withdrawn.
Withdrawal
A question-and-answer document on the withdrawal of marketing authorisation application for Belviq (lorcaserin) is also published.
More information on these and all other outcomes of the CHMP May 2013 meeting is available in the link below.