Clopidogrel/Acetylsalicylic acid Teva

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Withdrawn

This medicine's authorisation has been withdrawn

clopidogrel / acetylsalicylic acid
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

The marketing authorisation for Clopidogrel/Acetylsalicylic acid Teva has been withdrawn at the request of the marketing-authorisation holder.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

First published: 26/09/2014Last 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)

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Product information

Clopidogrel / Acetylsalicylic acid Teva : EPAR - Product Information

English (EN) (1.15 MB - PDF)

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български (BG) (2.74 MB - PDF)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

First published: 26/09/2014Last 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)

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български (BG) (559.88 KB - PDF)

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

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

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

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

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

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

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

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

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

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

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

First published: 26/09/2014Last updated: 28/04/2017
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lietuvių kalba (LT) (517.37 KB - PDF)

First published: 26/09/2014Last updated: 28/04/2017
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magyar (HU) (522.9 KB - PDF)

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

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

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

First published: 26/09/2014Last updated: 28/04/2017
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polski (PL) (498.85 KB - PDF)

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

First published: 26/09/2014Last updated: 28/04/2017
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română (RO) (513.43 KB - PDF)

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

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

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

First published: 26/09/2014Last updated: 28/04/2017
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svenska (SV) (466.42 KB - PDF)

First published: 26/09/2014Last 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
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

AdoptedReference Number: EMA/CHMP/333195/2014

English (EN) (1.5 MB - PDF)

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CHMP summary of positive opinion for Clopidogrel / Acetylsalicylic acid Teva

AdoptedReference Number: EMA/CHMP/369651/2014

English (EN) (563.03 KB - PDF)

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More information on Clopidogrel/Acetylsalicylic acid Teva

Public statement on Clopidogrel/Acetylsalicylic acid Teva: Withdrawal of the marketing authorisation in the European Union

Reference Number: EMA/252355/2017

English (EN) (65.62 KB - PDF)

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