Ivabradine Accord (ivabradine)
- Region
- 🇪🇺 EU
- Active substance
- ivabradine
- Company
- Accord Healthcare S.L.U.
- Status
- Authorised
- Therapeutic area
- Angina Pectoris; Heart Failure
- CHMP opinion
- Thu 23 Mar 2017
- EU approval
- Mon 22 May 2017
- Designations
- Generic
- Application
- EMEA/H/C/004241
- ATC
- C01EB17
- Official record
- www.ema.europa.eu
Indication
Symptomatic treatment of chronic stable angina pectoris Ivabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ? 70 bpm. Ivabradine is indicated : - in adults unable to tolerate or with a contra-indication to the use of beta-blockers - or in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose. Treatment of chronic heart failure Ivabradine is indicated in chronic heart failure NYHA II to IV class 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. (see section 5.1)
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Procoralan Authorised · Les Laboratoires Servier
- 🇪🇺 Ivabradine Anpharm Authorised · "Anpharm" Przedsiębiorstwo Farmaceutyczne S.A.
- 🇪🇺 Corlentor Authorised · Les Laboratoires Servier
- 🇪🇺 Ivabradine Zentiva Authorised · Zentiva k.s.
- 🇪🇺 Ivabradine JensonR Withdrawn · JensonR+ Limited
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.