Overview
The marketing authorisation for Clopidogrel Acino has been withdrawn at the request of the marketing-authorisation holder.
Clopidogrel Acino : EPAR - Summary for the public
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Product information
Clopidogrel Acino : EPAR - Product Information
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Latest procedure affecting product information: IB/0018/G
28/01/2016
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 Acino : EPAR - All Authorised presentations
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български (BG) (552.52 KB - PDF)
español (ES) (464.19 KB - PDF)
čeština (CS) (541.37 KB - PDF)
dansk (DA) (463.7 KB - PDF)
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eesti keel (ET) (464.07 KB - PDF)
ελληνικά (EL) (548.91 KB - PDF)
français (FR) (464.16 KB - PDF)
italiano (IT) (463.48 KB - PDF)
latviešu valoda (LV) (541.83 KB - PDF)
lietuvių kalba (LT) (532.37 KB - PDF)
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slovenščina (SL) (475.58 KB - PDF)
Suomi (FI) (463.95 KB - PDF)
svenska (SV) (464.15 KB - PDF)
Product details
- Name of medicine
- Clopidogrel Acino
- Active substance
- clopidogrel
- International non-proprietary name (INN) or common name
- clopidogrel
- Therapeutic area (MeSH)
- Peripheral Vascular Diseases
- Acute Coronary Syndrome
- Myocardial Infarction
- Stroke
- Anatomical therapeutic chemical (ATC) code
- B01AC04
Pharmacotherapeutic group
Antithrombotic agentsTherapeutic 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
- 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, in combination with acetylsalicylic acid (ASA)
- ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy
- Patients suffering from acute coronary syndrome.
Authorisation details
- EMA product number
- EMEA/H/C/001166
Generic
This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.
- Marketing authorisation holder
- Acino AG
Am Windfeld 35
DE-83714 Miesbach
Germany - Marketing authorisation issued
- 28/07/2009
- Revision
- 6
Assessment history
Clopidogrel Acino : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (606.04 KB - PDF)
Clopidogrel Acino-H-C-1166-A-20-4: EPAR - Assessment Report - Article 20
English (EN) (550.34 KB - PDF)
Clopidogrel Acino : EPAR - Public assessment report
English (EN) (713.31 KB - PDF)
Committee for medicinal products for human use summary of positive opinion for Clopidogrel Acino
English (EN) (494.67 KB - PDF)
More information on Clopidogrel Acino
Questions and answers on the precautionary recall of batches of clopidogrel-containing medicines
English (EN) (58.98 KB - PDF)
Public statement on Clopidogrel Acino: Withdrawal of the marketing authorisation in the European Union
English (EN) (65.67 KB - PDF)