🇪🇺 Corlanor in European Union

EMA authorised Corlanor on 25 October 2005

Marketing authorisations

Application: EMEA/H/C/000597
Marketing authorisation holder: Les Laboratoires Servier
Local brand name: Procoralan
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 contraindication 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 sinu
Status: approved

Application: EMEA/H/C/000598
Marketing authorisation holder: Les Laboratoires Servier
Local brand name: Corlentor
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 contraindication 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 r
Status: approved

Application: EMEA/H/C/004187
Marketing authorisation holder: "Anpharm" Przedsiębiorstwo Farmaceutyczne S.A.
Local brand name: Ivabradine Anpharm
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 betablocker 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 r
Status: approved

Application: EMEA/H/C/004117
Marketing authorisation holder: Zentiva, k.s.
Local brand name: Ivabradine Zentiva
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
Status: approved

Application: EMEA/H/C/004217
Marketing authorisation holder: JensonR+ Limited
Local brand name: Ivabradine JensonR
Indication: 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 includin
Status: withdrawn

Application: EMEA/H/C/004241
Marketing authorisation holder: Accord Healthcare S.L.U.
Local brand name: Ivabradine Accord
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 sin
Status: approved

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Is Corlanor approved in European Union?

Yes. EMA authorised it on 25 October 2005; EMA authorised it on 25 October 2005; EMA authorised it on 25 October 2005.

Who is the marketing authorisation holder for Corlanor in European Union?

Les Laboratoires Servier holds the EU marketing authorisation.