Clopidogrel Acino Pharma GmbH

clopidogrel

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The marketing authorisation for Clopidogrel Acino Pharma GmbH has been withdrawn at the request of the marketing-authorisation holder.

Name Language First published Last updated
Clopidogrel Acino Pharma GmbH : EPAR - Summary for the public BG = bălgarski 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - Summary for the public ES = español 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - Summary for the public CS = čeština 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - Summary for the public DA = dansk 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - Summary for the public DE = Deutsch 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - Summary for the public ET = eesti keel 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - Summary for the public EL = elliniká 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - Summary for the public EN = English 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - Summary for the public FR = français 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - Summary for the public IT = italiano 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - Summary for the public LV = latviešu valoda 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - Summary for the public LT = lietuvių kalba 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - Summary for the public HU = magyar 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - Summary for the public MT = Malti 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - Summary for the public NL = Nederlands 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - Summary for the public PL = polski 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - Summary for the public PT = português 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - Summary for the public RO = română 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - Summary for the public SK = slovenčina 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - Summary for the public SL = slovenščina 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - Summary for the public FI = suomi 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - Summary for the public SV = svenska 2009-10-16 2012-07-26

This EPAR was last updated on 26/07/2012 .

More detail is available in the summary of product characteristics

Authorisation details

Product details

Product details for Clopidogrel Acino Pharma GmbH
NameClopidogrel Acino Pharma GmbH
Agency product numberEMEA/H/C/001175
Active substance

clopidogrel

International non-proprietary name (INN) or common name

clopidogrel

Therapeutic area Peripheral Vascular DiseasesStrokeMyocardial Infarction
Anatomical therapeutic chemical (ATC) code B01AC04
Generic

A generic medicine is a medicine which is similar to a medicine that has already been authorised (the 'reference medicine'). A generic medicine contains the same quantity of active substance(s) as the reference medicine. Generic and reference medicines are used at the same dose to treat the same disease, and they are equally safe and effective.

Publication details

Publication details for Clopidogrel Acino Pharma GmbH
Marketing-authorisation holder

Acino Pharma GmbH

Revision1
Date of issue of marketing authorisation valid throughout the European Union21/09/2009

Contact address:

Acino Pharma GmbH
Am Windfeld 35
83714 Miesbach
Germany

Product information

Product information

13/02/2012  Clopidogrel Acino Pharma GmbH -EMEA/H/C/001175 -A20/04

Name Language First published Last updated
Clopidogrel Acino Pharma GmbH : EPAR - Product Information SV = svenska 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - Product Information SV = svenska 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - Product Information SV = svenska 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - Product Information SV = svenska 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - Product Information SV = svenska 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - Product Information SV = svenska 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - Product Information SV = svenska 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - Product Information SV = svenska 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - Product Information SV = svenska 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - Product Information SV = svenska 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - Product Information SV = svenska 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - Product Information SV = svenska 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - Product Information SV = svenska 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - Product Information SV = svenska 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - Product Information SV = svenska 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - Product Information SV = svenska 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - Product Information SV = svenska 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - Product Information SV = svenska 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - Product Information SV = svenska 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - Product Information SV = svenska 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - Product Information SV = svenska 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - Product Information SV = svenska 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - Product Information SV = svenska 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - Product Information SV = svenska 2009-10-16 2012-07-26

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.

Name Language First published Last updated
Clopidogrel Acino Pharma GmbH : EPAR - All Authorised presentations SV = svenska 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - All Authorised presentations SV = svenska 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - All Authorised presentations SV = svenska 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - All Authorised presentations SV = svenska 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - All Authorised presentations SV = svenska 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - All Authorised presentations SV = svenska 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - All Authorised presentations SV = svenska 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - All Authorised presentations SV = svenska 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - All Authorised presentations SV = svenska 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - All Authorised presentations SV = svenska 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - All Authorised presentations SV = svenska 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - All Authorised presentations SV = svenska 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - All Authorised presentations SV = svenska 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - All Authorised presentations SV = svenska 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - All Authorised presentations SV = svenska 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - All Authorised presentations SV = svenska 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - All Authorised presentations SV = svenska 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - All Authorised presentations SV = svenska 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - All Authorised presentations SV = svenska 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - All Authorised presentations SV = svenska 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - All Authorised presentations SV = svenska 2009-10-16 2012-07-26
Clopidogrel Acino Pharma GmbH : EPAR - All Authorised presentations SV = svenska 2009-10-16 2012-07-26

Pharmacotherapeutic group

Antithrombotic agents

Therapeutic indication

Clopidogrel is indicated in adults for the prevention of atherothrombotic events in:

  • patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.

For further information please refer to section 5.1.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Clopidogrel Acino Pharma GmbH : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2011-03-31 2012-07-26
Clopidogrel Acino Pharma GmbH-H-C-1175-A20-04 : EPAR - Assessment Report - Variation SV = svenska 2011-03-31 2012-07-26

Initial marketing-authorisation documents

Name Language First published Last updated
Clopidogrel Acino Pharma GmbH : EPAR - Public assessment report SV = svenska 2009-10-16 2012-07-26
CHMP summary of positive opinion for Clopidogrel Acino Pharma GmbH SV = svenska 2009-06-25  

Withdrawn

This medicine is now withdrawn from use in the European Union

More information on Clopidogrel Acino Pharma GmbH