Overview
The marketing authorisation for Clopidogrel Acino Pharma has been withdrawn at the request of the marketing-authorisation holder.
Clopidogrel Acino Pharma : EPAR - Summary for the public
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Product information
Clopidogrel Acino Pharma : EPAR - Product Information
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Latest procedure affecting product information: A20/0004
09/02/2012
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 Pharma : EPAR - All Authorised presentations
English (EN) (458.6 KB - PDF)
български (BG) (326.17 KB - PDF)
español (ES) (226.07 KB - PDF)
čeština (CS) (299.25 KB - PDF)
dansk (DA) (243.5 KB - PDF)
Deutsch (DE) (225.49 KB - PDF)
eesti keel (ET) (225.9 KB - PDF)
ελληνικά (EL) (323.64 KB - PDF)
français (FR) (229.09 KB - PDF)
italiano (IT) (225 KB - PDF)
latviešu valoda (LV) (304.69 KB - PDF)
lietuvių kalba (LT) (309.26 KB - PDF)
magyar (HU) (301.61 KB - PDF)
Malti (MT) (300.19 KB - PDF)
Nederlands (NL) (225.42 KB - PDF)
polski (PL) (265.93 KB - PDF)
português (PT) (225.68 KB - PDF)
română (RO) (290.89 KB - PDF)
slovenčina (SK) (264.24 KB - PDF)
slovenščina (SL) (234.82 KB - PDF)
Suomi (FI) (228.74 KB - PDF)
svenska (SV) (225.4 KB - PDF)
Product details
- Name of medicine
- Clopidogrel Acino Pharma
- Active substance
- clopidogrel
- International non-proprietary name (INN) or common name
- clopidogrel
- Therapeutic area (MeSH)
- Peripheral Vascular Diseases
- Stroke
- Myocardial Infarction
- 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.
For further information please refer to section 5.1.
Authorisation details
- EMA product number
- EMEA/H/C/001172
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 Pharma GmbH
Am Windfeld 35
83714 Miesbach
Germany - Marketing authorisation issued
- 21/09/2009
- Revision
- 1
Assessment history
Clopidogrel Acino Pharma : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (577.11 KB - PDF)
Clopidogrel Acino Pharma-H-C-1172-A20-04: EPAR - Assessment Report - Variation
English (EN) (552.56 KB - PDF)
Clopidogrel Acino Pharma : EPAR - Public assessment report
English (EN) (816.94 KB - PDF)
Committee for medicinal products for human use summary of positive opinion for Clopidogrel Acino Pharma
English (EN) (32.84 KB - PDF)
More information on Clopidogrel Acino Pharma
Public statement on Clopidogrel Acino Pharma: Withdrawal of the marketing authorisation in the European Union
English (EN) (43.29 KB - PDF)
Questions and answers on the precautionary recall of batches of clopidogrel-containing medicines
English (EN) (58.98 KB - PDF)