Clopidogrel/Acetylsalicylic acid Teva
clopidogrel / acetylsalicylic acid
Table of contents
Overview
The marketing authorisation for Clopidogrel/Acetylsalicylic acid Teva has been withdrawn at the request of the marketing-authorisation holder.
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Clopidogrel / Acetylsalicylic acid Teva : EPAR - Summary for the public (PDF/551.84 KB)
First published: 26/09/2014
Last updated: 28/04/2017
EMA/558791/2014 -
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Clopidogrel / Acetylsalicylic acid Teva : EPAR - Risk-management-plan summary (PDF/554.72 KB)
First published: 26/09/2014
Last updated: 28/04/2017
EMA/411850/2014
Authorisation details
| Product details | |
|---|---|
| Name |
Clopidogrel/Acetylsalicylic acid Teva
|
| Agency product number |
EMEA/H/C/002272
|
| Active substance |
|
| International non-proprietary name (INN) or common name |
|
| Therapeutic area (MeSH) |
|
| Anatomical therapeutic chemical (ATC) code |
B01AC30
|
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Teva Pharma B.V.
|
| Revision |
1
|
| Date of issue of marketing authorisation valid throughout the European Union |
01/09/2014
|
| Contact address |
Swensweg 5
2031GA Haarlem The Netherlands |
Product information
03/06/2016 Clopidogrel/Acetylsalicylic acid Teva - EMEA/H/C/002272 - IA/0002
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
Therapeutic indication
Clopidogrel/Acetylsalicylic acid Teva is indicated for the prevention of atherothrombotic events in adult patients already taking both clopidogrel and acetylsalicylic acid (ASA). Clopidogrel/Acetylsalicylic acid Teva is a fixed‑dose combination medicinal product for continuation of therapy in:
- Non‑ST segment elevation acute coronary syndrome (unstable angina or non‑Q‑wave myocardial infarction) including patients undergoing a stent placement following percutaneous coronary intervention
ST segment elevation acute myocardial infarction in medically treated patients eligible for thrombolytic therapy