EMA - stanoviska přijatá v září
Přehled stanovisek přijatých v září 2013 zasedáním Výboru pro humánní léčivé přípravky (CHMP) Evropské lékové agentury (EMA):
Eleven new medicines recommended for approval
The CHMP recommended the approval of two medicines for cancer: Kadcyla for the treatment of metastatic breast cancer and Xofigo for the treatment of castration-resistant prostate cancer.
The Committee also gave positive recommendations for three medicines intended to treat neurological disorders: Abilify Maintena for the treatment of schizophrenia, Memantine Accord, a generic medicine, for the treatment of Alzheimer’s disease and Levodopa Carbidopa Entacapone Sandoz, which was submitted as a so-called informed consent application,for the treatment of adult patients with Parkinson’s disease.
The CHMP also recommended that Vitekta should be granted marketing authorisation for the treatment of human immunodeficiency virus‑1 (HIV‑1) infection in adults who are infected with HIV‑1 without known mutations associated with resistance to elvitegravir.
Invokana received a positive opinion for marketing authorisation for the treatment of type 2 diabetes mellitus.
NovoEight was recommended for marketing authorisation for the treatment of haemophilia A and Relvar Ellipta received a positive opinion from the Committee for the treatment of asthma and chronic obstructive pulmonary disorder (COPD).
The vaccine Fluenz Tetra was recommended for a marketing authorisation for the prevention of influenza in children and adolescents 24 months to less than 18 years of age.
The Committee recommended that Lidocaine / Prilocaine Plethora should be granted marketing authorisation for the treatment of primary premature ejaculation in adult men.
Four recommendations on extensions of therapeutic indications
The CHMP recommended an extension to the existing indications for Cimzia, Kineret, Votubia and Yervoy.
Two re-examination procedures for referral opinions started
The CHMP started a re-examination procedure for dihydroergotoxine, one of the medicines included in the Article-31 referral procedure on ergot derivatives. The other ergot derivatives in this referral are not included in this re-examination.
The Committee also started a re-examination procedure for metoclopramide-containing medicines.
Čerpáno z www.ema.europa.eu