NeLM news service
European CHMP recommends approval of license extension for ivabradine (Procoralan) as treatment of chronic heart failure (NYHA II to IV) and updates contra-indications

Source: European Medicines Agency (EMA)

Date published: 16/12/2011 17:40

Summary
by: Yuet Wan

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of license extension of ivabradine (Procoralan) to include the treatment of chronic heart failure NYHA II to IV with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.

The CHMP adopted a new contraindication as follows:
• unstable or acute heart failure
• pacemaker dependent (heart rate imposed exclusively by the pacemaker)

The CHMP also adopted the removal of a contraindication as follows: “heart failure patients with NYHA class III-IV

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