Ranexa (previously Latixa)

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ranolazine

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

This EPAR was last updated on 06/10/2017

Authorisation details

Product details
Name
Ranexa (previously Latixa)
Agency product number
EMEA/H/C/000805
Active substance
ranolazine
International non-proprietary name (INN) or common name
ranolazine
Therapeutic area (MeSH)
Angina Pectoris
Anatomical therapeutic chemical (ATC) code
C01EB18
Publication details
Marketing-authorisation holder
Menarini International Operations Luxembourg S.A. (MIOL)
Revision
15
Date of issue of marketing authorisation valid throughout the European Union
08/07/2008
Contact address
Menarini International Operations Luxembourg S.A.
1, Avenue de la Gare
L-1611 Luxembourg
Luxembourg

Product information

02/08/2017 Ranexa (previously Latixa) - EMEA/H/C/000805 - IAIN/0052/G

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

CARDIAC THERAPY

Therapeutic indication

Ranexa is indicated as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line anti-anginal therapies (such as beta-blockers and / or calcium antagonists).

Assessment history

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