Overview
The marketing authorisation for Clopidogrel Ratiopharm GmbH has been withdrawn at the request of the marketing-authorisation holder.
Clopidogrel ratiopharm GmbH : EPAR - Summary for the public
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Product information
Clopidogrel ratiopharm GmbH : EPAR - Product Information
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Suomi (FI) (886.54 KB - PDF)
svenska (SV) (1.1 MB - PDF)
Latest procedure affecting product information: IAIN/0036
22/08/2019
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 ratiopharm GmbH : EPAR - All Authorised presentations
English (EN) (574.5 KB - PDF)
български (BG) (1.2 MB - PDF)
español (ES) (1.12 MB - PDF)
čeština (CS) (1.19 MB - PDF)
dansk (DA) (1.12 MB - PDF)
Deutsch (DE) (1.12 MB - PDF)
eesti keel (ET) (1.12 MB - PDF)
ελληνικά (EL) (1.2 MB - PDF)
français (FR) (1.12 MB - PDF)
italiano (IT) (1.12 MB - PDF)
latviešu valoda (LV) (1.2 MB - PDF)
lietuvių kalba (LT) (1.18 MB - PDF)
magyar (HU) (1.2 MB - PDF)
Malti (MT) (1.19 MB - PDF)
Nederlands (NL) (1.12 MB - PDF)
polski (PL) (1.16 MB - PDF)
português (PT) (1.12 MB - PDF)
română (RO) (1.18 MB - PDF)
slovenčina (SK) (1.16 MB - PDF)
slovenščina (SL) (1.13 MB - PDF)
Suomi (FI) (1.12 MB - PDF)
svenska (SV) (1.12 MB - PDF)
Product details
- Name of medicine
- Clopidogrel ratiopharm GmbH
- 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;
- patients suffering from acute coronary syndrome:
- 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.
Authorisation details
- EMA product number
- EMEA/H/C/001165
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
- Archie Samiel s.r.o.
Slunná 16
61700 Brno
Czech Republic - Marketing authorisation issued
- 28/07/2009
- Revision
- 12
Assessment history
Clopidogrel ratiopharm GmbH : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (700.68 KB - PDF)
Clopidogrel ratiopharm GmbH-H-C-1165-A20-09 : EPAR - Assessment Report - Article 20
English (EN) (720.38 KB - PDF)
More information on Clopidogrel Ratiopharm GmbH
Public statement on Clopidogrel ratiopharm GmbH: Withdrawal of the marketing authorisation in the European Union
English (EN) (129.56 KB - PDF)
Questions and answers on the precautionary recall of batches of clopidogrel-containing medicines
English (EN) (58.98 KB - PDF)
Questions and answers on generic medicines
English (EN) (66.45 KB - PDF)
български (BG) (93.16 KB - PDF)
español (ES) (68.3 KB - PDF)
čeština (CS) (87.71 KB - PDF)
dansk (DA) (66.79 KB - PDF)
Deutsch (DE) (67.55 KB - PDF)
eesti keel (ET) (65.21 KB - PDF)
ελληνικά (EL) (91.29 KB - PDF)
français (FR) (68.35 KB - PDF)
hrvatski (HR) (87.8 KB - PDF)
italiano (IT) (67.62 KB - PDF)
latviešu valoda (LV) (111.81 KB - PDF)
lietuvių kalba (LT) (86.76 KB - PDF)
magyar (HU) (85.76 KB - PDF)
Malti (MT) (89.35 KB - PDF)
Nederlands (NL) (66.81 KB - PDF)
polski (PL) (88.51 KB - PDF)
português (PT) (68.32 KB - PDF)
română (RO) (86.9 KB - PDF)
slovenčina (SK) (87.73 KB - PDF)
slovenščina (SL) (84.8 KB - PDF)
Suomi (FI) (66.21 KB - PDF)
svenska (SV) (67.11 KB - PDF)