New EMA approvals

May 27, 2014

THE European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended varying levels of marketing authorisation for six new products. The approvals are for Gazyvaro (obinutuzumab), Plegridy (peginterferon beta-1a), Nuwiq (simoctogog alfa), Simbrinza (brinzolamide / brimonidine tartrate) and Envarsus (tacrolimus). Additionally, the CHMP recommended extensions of indications for Arzerra (ofatumumab), Halaven (eribulin mesylate) and Vfend (Voriconazole). The CHMP also recommended a conditional marketing authorisation for Translarna (ataluren), an orphan medicine for the treatment of Duchenne muscular dystrophy caused by nonsense mutations. It is to be used for patients aged five years or older who are able to walk.

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Pharmacy Daily | New EMA approvals

New EMA approvals

Other recent headlines

Upskill with new MMR microcredential

Female pharmacists are still held back

Business travellers at risk

SEARCH PHARMACY DAILY

Featured video

Recent issues

INDUSTRY JOB VACANCIES