CHMP News - February 2014
The CHMP has recommended ten new medicinal products by adopting the following recommendations:
- the CHMP has recommended granting a so-called paediatric-use marketing authorisation (PUMA) for Hemangiol (propranolol):
- the CHMP has recommended for marketing authorisations four medicines for the treatment of symptoms in adult patients with chronic obstructive pulmonary disease (COPD): Anoro (umeclidinium bromide/vilanterol), Laventair (umeclidinium bromide/vilanterol), Incruase (umeclidinium bromide), Ulunar Breezhaler (indacaterol/glycopyrronium bromide):
- the CHMP has recommended for marketing authorisation two medicines for the treatment of asthma and COPD: DuoResp Spiromax (budesonide/formoterol) and BiResp Spiromax (budesonide/formoterol):
- the CHMP has recommended for marketing authorisation Vimizim (elosulfase alfa) for the treatment of mucopolysaccharidosis type IVA. Vimizim has an orpgan designation;
- the CHMP has recommended for marketing authorisation Vokanamet (canagliflozin/metformin) for the treatment of type 2 diabetes;
- the CHMP has recommended for marketing authorisation Pregabalin Pfizer (pregabalin) for the treatment of neuropathic pain, epilepsy and general anxiety disorder.
The CHMP also adopted recommendations in two referral procedures for methysergide-containing medicines and Protelos/Osseor, about which HALMED reported on its webpages on the 24 February 2014.
Furthermore, the CHMP has given an opinion on the use of a fixed-dose combination of ledipasvir and sofosbuvir for the treatment of chronic (long-term) hepatitis C virus (HCV) infection, compassionate-use programme.