Overview
The marketing authorisation for Clopidogrel Sandoz has been withdrawn at the request of the marketing authorisation holder.
Clopidogrel Sandoz : EPAR - Summary for the public
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Product information
Clopidogrel Sandoz : EPAR - Product Information
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Latest procedure affecting product information: A20/0007
16/09/2010
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 Sandoz : EPAR - All Authorised presentations
English (EN) (663.81 KB - PDF)
български (BG) (325.11 KB - PDF)
español (ES) (243.73 KB - PDF)
čeština (CS) (316.81 KB - PDF)
dansk (DA) (243.47 KB - PDF)
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eesti keel (ET) (240.62 KB - PDF)
ελληνικά (EL) (322.68 KB - PDF)
français (FR) (244.35 KB - PDF)
italiano (IT) (240.08 KB - PDF)
latviešu valoda (LV) (318.64 KB - PDF)
lietuvių kalba (LT) (308.68 KB - PDF)
magyar (HU) (317.82 KB - PDF)
Malti (MT) (316.61 KB - PDF)
Nederlands (NL) (242.96 KB - PDF)
polski (PL) (283.16 KB - PDF)
português (PT) (240.51 KB - PDF)
română (RO) (305.14 KB - PDF)
slovenčina (SK) (279.22 KB - PDF)
slovenščina (SL) (252.55 KB - PDF)
Suomi (FI) (243.44 KB - PDF)
svenska (SV) (243.68 KB - PDF)
Product details
- Name of medicine
- Clopidogrel Sandoz
- 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/001174
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
- 2
Assessment history
Clopidogrel Sandoz : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (61.13 KB - PDF)
Clopidogrel Sandoz-H-001174-A-20-0007 : EPAR - Assessment Report - Variation
English (EN) (310.72 KB - PDF)
More information on Clopidogrel Sandoz
Public statement on Clopidogrel Sandoz: Withdrawal of the marketing authorisation in the European Union
English (EN) (53.3 KB - PDF)
Questions and answers on the precautionary recall of batches of clopidogrel-containing medicines
English (EN) (58.98 KB - PDF)