Clopidogrel/Acetylsalicylic acid Teva

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Withdrawn

This medicine's authorisation has been withdrawn

clopidogrel / acetylsalicylic acid
Medicine Human Withdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

On 3 June 2016, the European Commission withdrew the marketing authorisation for Clopidogrel/Acetylsalicylic acid Teva (clopidogrel / acetylsalicylic acid) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Teva Pharma B.V., which notified the European Commission of its decision not to market the product in the EU for commercial reasons. 

Clopidogrel/Acetylsalicylic acid Teva was granted marketing authorisation in the EU on 1 September 2014 for the prevention of atherothrombotic events. Clopidogrel/Acetylsalicylic acid Teva is a medicine that contains two active substances, clopidogrel and acetylsalicylic. There are other medicinal products marketed in the EU that contain this combination of substances as well as products containing clopidogrel or acetylsalicylic alone. 

The European Public Assessment Report (EPAR) for Clopidogrel/Acetylsalicylic acid Teva is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

Clopidogrel / Acetylsalicylic acid Teva : EPAR - Summary for the public

Reference Number: EMA/558791/2014

English (EN) (551.84 KB - PDF)

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български (BG) (640.29 KB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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español (ES) (551.49 KB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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čeština (CS) (619.76 KB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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dansk (DA) (553.34 KB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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Deutsch (DE) (552.85 KB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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ελληνικά (EL) (644.13 KB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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français (FR) (552.72 KB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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hrvatski (HR) (572.63 KB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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italiano (IT) (572.75 KB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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latviešu valoda (LV) (616.07 KB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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lietuvių kalba (LT) (579.55 KB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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magyar (HU) (611.27 KB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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Malti (MT) (621.63 KB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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Nederlands (NL) (549.73 KB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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polski (PL) (618.45 KB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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português (PT) (551.97 KB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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română (RO) (577.7 KB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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slovenčina (SK) (616.92 KB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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slovenščina (SL) (608.26 KB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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Suomi (FI) (548.85 KB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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svenska (SV) (550.28 KB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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Clopidogrel / Acetylsalicylic acid Teva : EPAR - Risk-management-plan summary

Reference Number: EMA/411850/2014

English (EN) (554.72 KB - PDF)

First published: Last updated:
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Product information

Clopidogrel / Acetylsalicylic acid Teva : EPAR - Product Information

English (EN) (1.15 MB - PDF)

First published: Last updated:
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български (BG) (2.74 MB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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español (ES) (1.22 MB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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čeština (CS) (2.14 MB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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dansk (DA) (1.17 MB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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Deutsch (DE) (1.21 MB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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eesti keel (ET) (1.15 MB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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ελληνικά (EL) (2.84 MB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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français (FR) (1.23 MB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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hrvatski (HR) (1.26 MB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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íslenska (IS) (1.2 MB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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italiano (IT) (1.41 MB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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latviešu valoda (LV) (2.16 MB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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lietuvių kalba (LT) (1.27 MB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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magyar (HU) (2.22 MB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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Malti (MT) (2.24 MB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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Nederlands (NL) (1.19 MB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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norsk (NO) (1.16 MB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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polski (PL) (2.29 MB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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português (PT) (1.2 MB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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română (RO) (1.26 MB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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slovenčina (SK) (2.24 MB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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slovenščina (SL) (2.09 MB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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Suomi (FI) (1.31 MB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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svenska (SV) (1.16 MB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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Latest procedure affecting product information:IA/0002
03/06/2016
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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).

Clopidogrel / Acetylsalicylic acid Teva : EPAR - All Authorised presentations

English (EN) (465.95 KB - PDF)

First published: Last updated:
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български (BG) (559.88 KB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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español (ES) (466.06 KB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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čeština (CS) (525.42 KB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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dansk (DA) (466.53 KB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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Deutsch (DE) (467.23 KB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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eesti keel (ET) (470.64 KB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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ελληνικά (EL) (538.45 KB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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français (FR) (466.03 KB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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hrvatski (HR) (514.42 KB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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íslenska (IS) (465.5 KB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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italiano (IT) (467.22 KB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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latviešu valoda (LV) (528.72 KB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
View

lietuvių kalba (LT) (517.37 KB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
View

magyar (HU) (522.9 KB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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Malti (MT) (559.02 KB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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Nederlands (NL) (465.99 KB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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norsk (NO) (465.81 KB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
View

polski (PL) (498.85 KB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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português (PT) (466.07 KB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
View

română (RO) (513.43 KB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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slovenčina (SK) (542.59 KB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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slovenščina (SL) (525.83 KB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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Suomi (FI) (467.09 KB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
View

svenska (SV) (466.42 KB - PDF)

First published: 26/09/2014 Last updated: 28/04/2017
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Product details

Name of medicine
Clopidogrel/Acetylsalicylic acid Teva
Active substance
  • clopidogrel
  • acetylsalicylic acid
International non-proprietary name (INN) or common name
  • clopidogrel
  • acetylsalicylic acid
Therapeutic area (MeSH)
  • Acute Coronary Syndrome
  • Myocardial Infarction
Anatomical therapeutic chemical (ATC) code
B01AC30

Pharmacotherapeutic group

combinations

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

Authorisation details

EMA product number
EMEA/H/C/002272
Marketing authorisation holder
Teva Pharma B.V.

Swensweg 5
2031GA Haarlem
The Netherlands

Opinion adopted
26/06/2014
Marketing authorisation issued
01/09/2014
Withdrawal of marketing authorisation
03/06/2016
Revision
1

Assessment history

Clopidogrel/Acetylsalicylic acid Teva : EPAR - Procedural steps taken and scientific information after authorisation

English (EN) (523.44 KB - PDF)

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Clopidogrel / Acetylsalicylic acid Teva : EPAR - Public assessment report

Adopted Reference Number: EMA/CHMP/333195/2014

English (EN) (1.5 MB - PDF)

First published: Last updated:
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CHMP summary of positive opinion for Clopidogrel / Acetylsalicylic acid Teva

Adopted Reference Number: EMA/CHMP/369651/2014

English (EN) (563.03 KB - PDF)

First published: Last updated:
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