Ranexa (previously Latixa)
ranolazine
Table of contents
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).
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Ranexa : EPAR - Summary for the public (PDF/106.71 KB)
First published: 14/09/2009
Last updated: 08/10/2021 -
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Ranexa : EPAR - Risk-management-plan summary (PDF/111.54 KB)
First published: 28/09/2021
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 |
22
|
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
10/08/2022 Ranexa (previously Latixa) - EMEA/H/C/000805 - N/0068
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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).