FDAnews Drug Daily Bulletin

CHMP Recommends 7 Drugs for Approval in the EU

Jan. 5, 2017

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended seven new medicines for approval in the EU.

The seven medicines include: Roche’s Alecensa; Pfizer’s Lifmior; Eli Lilly’s Olumiant; Octapharma’s Vihuma; Zentiva‘s Pregabalin; Actelion’s Ledaga; and Celltrion’s Truxima.

In addition, the CHMP recommended extensions of indication for nine more medicines and confirmed the recommendation of the Pharmacovigilance Risk Assessment Committee to screen all patients for hepatitis B before starting treatment with direct-acting antivirals for hepatitis C; patients infected with both hepatitis B and C viruses must be monitored and managed according to current clinical guidelines.

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