Clopidogrel ratiopharm GmbH

clopidogrel

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This is a summary of the European public assessment report (EPAR) for Clopidogrel ratiopharm GmbH. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Clopidogrel ratiopharm GmbH.

What is Clopidogrel ratiopharm GmbH?

Clopidogrel ratiopharm GmbH is a medicine that contains the active substance clopidogrel. It is available as tablets (75 mg).

Clopidogrel ratiopharm GmbH is a ‘generic medicine’. This means that Clopidogrel ratiopharm GmbH is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Plavix.

What is Clopidogrel ratiopharm GmbH used for?

Clopidogrel ratiopharm GmbH is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries). Clopidogrel ratiopharm GmbH can be given to the following groups of patients:

  • patients who have recently had a myocardial infarction (heart attack). Clopidogrel ratiopharm GmbH can be started between a few days and 35 days after the attack;
  • patients who have had a recent ischaemic stroke (stroke caused by failure of the blood supply to part of the brain). Clopidogrel ratiopharm GmbH can be started between seven days and six months after the stroke;
  • patients with peripheral arterial disease (problems with blood flow in the arteries);
  • patients who have a condition known as ‘acute coronary syndrome’, when it should be given with aspirin (another medicine that prevents blood clots), including patients who have had a stent inserted (a short tube placed in an artery to prevent it closing up). Clopidogrel ratiopharm GmbH can be used in patients who are having myocardial infarction with ‘ST segment elevation’ (an abnormal reading on the electrocardiogram or ECG) when the doctor thinks that they would benefit from the treatment. It can also be used in patients who do not have this abnormal reading on the ECG, if they have unstable angina (a severe type of chest pain) or have had a ‘non‑Q‑wave’ myocardial infarction.

The medicine can only be obtained with a prescription.

How is Clopidogrel ratiopharm GmbH used?

The standard dose of Clopidogrel ratiopharm GmbH is one 75 mg tablet once a day. In acute coronary syndrome, Clopidogrel ratiopharm GmbH is used together with aspirin and treatment generally starts with a loading dose of four 75 mg tablets. This is then followed by the standard 75 mg dose once a day for at least four weeks (in ST segment elevation myocardial infarction) or for up to 12 months (in non‑ST segment elevation syndrome).

How does Clopidogrel ratiopharm GmbH work?

The active substance in Clopidogrel ratiopharm GmbH, clopidogrel, is an inhibitor of platelet aggregation. This means that it helps to prevent blood clots from forming. When the blood clots, this is due to special cells in the blood called platelets aggregating (sticking together). Clopidogrel stops the platelets aggregating by blocking a substance called ADP from attaching to a special receptor on their surface. This stops the platelets becoming ‘sticky’, reducing the risk of a blood clot forming and helping to prevent another heart attack or stroke.

How has Clopidogrel ratiopharm GmbH been studied?

Because Clopidogrel ratiopharm GmbH is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What are the benefit and risk of Clopidogrel ratiopharm GmbH?

Because Clopidogrel ratiopharm GmbH is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine’s.

Why has Clopidogrel ratiopharm GmbH been approved?

The CHMP concluded that, in accordance with EU requirements, Clopidogrel ratiopharm GmbH has been shown to have comparable quality and to be bioequivalent to Plavix. Therefore, the CHMP’s view was that, as for Plavix, the benefit outweighs the identified risk. The Committee recommended that Clopidogrel ratiopharm GmbH be given marketing authorisation.

Other information about Clopidogrel ratiopharm GmbH

The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel ratiopharm GmbH on 28 July 2009.

For more information about treatment with Clopidogrel ratiopharm GmbH, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Clopidogrel ratiopharm GmbH : EPAR - Summary for the public BG = bălgarski 2009-09-08 2013-02-28
Clopidogrel ratiopharm GmbH : EPAR - Summary for the public ES = español 2009-09-08 2013-02-28
Clopidogrel ratiopharm GmbH : EPAR - Summary for the public CS = čeština 2009-09-08 2013-02-28
Clopidogrel ratiopharm GmbH : EPAR - Summary for the public DA = dansk 2009-09-08 2013-02-28
Clopidogrel ratiopharm GmbH : EPAR - Summary for the public DE = Deutsch 2009-09-08 2013-02-28
Clopidogrel ratiopharm GmbH : EPAR - Summary for the public ET = eesti keel 2009-09-08 2013-02-28
Clopidogrel ratiopharm GmbH : EPAR - Summary for the public EL = elliniká 2009-09-08 2013-02-28
Clopidogrel ratiopharm GmbH : EPAR - Summary for the public EN = English 2009-09-08 2013-02-28
Clopidogrel ratiopharm GmbH : EPAR - Summary for the public FR = français 2009-09-08 2013-02-28
Clopidogrel ratiopharm GmbH : EPAR - Summary for the public IT = italiano 2009-09-08 2013-02-28
Clopidogrel ratiopharm GmbH : EPAR - Summary for the public LV = latviešu valoda 2009-09-08 2013-02-28
Clopidogrel ratiopharm GmbH : EPAR - Summary for the public LT = lietuvių kalba 2009-09-08 2013-02-28
Clopidogrel ratiopharm GmbH : EPAR - Summary for the public HU = magyar 2009-09-08 2013-02-28
Clopidogrel ratiopharm GmbH : EPAR - Summary for the public MT = Malti 2009-09-08 2013-02-28
Clopidogrel ratiopharm GmbH : EPAR - Summary for the public NL = Nederlands 2009-09-08 2013-02-28
Clopidogrel ratiopharm GmbH : EPAR - Summary for the public PL = polski 2009-09-08 2013-02-28
Clopidogrel ratiopharm GmbH : EPAR - Summary for the public PT = português 2009-09-08 2013-02-28
Clopidogrel ratiopharm GmbH : EPAR - Summary for the public RO = română 2009-09-08 2013-02-28
Clopidogrel ratiopharm GmbH : EPAR - Summary for the public SK = slovenčina 2009-09-08 2013-02-28
Clopidogrel ratiopharm GmbH : EPAR - Summary for the public SL = slovenščina 2009-09-08 2013-02-28
Clopidogrel ratiopharm GmbH : EPAR - Summary for the public FI = suomi 2009-09-08 2013-02-28
Clopidogrel ratiopharm GmbH : EPAR - Summary for the public SV = svenska 2009-09-08 2013-02-28

This EPAR was last updated on 08/05/2018 .

Authorisation details

Product details

Product details for Clopidogrel ratiopharm GmbH
NameClopidogrel ratiopharm GmbH
Agency product numberEMEA/H/C/001165
Active substance

clopidogrel

International non-proprietary name (INN) or common name

clopidogrel

Therapeutic area Peripheral Vascular DiseasesStrokeAcute Coronary SyndromeMyocardial 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 ratiopharm GmbH
Marketing-authorisation holder

Archie Samiel s.r.o.

Revision10
Date of issue of marketing authorisation valid throughout the European Union28/07/2009

Contact address:

Archie Samiel s.r.o.
Slunná 16
61700 Brno
Czech Republic

Product information

Product information

13/04/2018  Clopidogrel ratiopharm GmbH -EMEA/H/C/001165 -IB/0034

Name Language First published Last updated
Clopidogrel ratiopharm GmbH : EPAR - Product Information SV = svenska 2009-10-13 2018-05-08
Clopidogrel ratiopharm GmbH : EPAR - Product Information SV = svenska 2009-10-13 2018-05-08
Clopidogrel ratiopharm GmbH : EPAR - Product Information SV = svenska 2009-10-13 2018-05-08
Clopidogrel ratiopharm GmbH : EPAR - Product Information SV = svenska 2009-10-13 2018-05-08
Clopidogrel ratiopharm GmbH : EPAR - Product Information SV = svenska 2009-10-13 2018-05-08
Clopidogrel ratiopharm GmbH : EPAR - Product Information SV = svenska 2009-10-13 2018-05-08
Clopidogrel ratiopharm GmbH : EPAR - Product Information SV = svenska 2009-10-13 2018-05-08
Clopidogrel ratiopharm GmbH : EPAR - Product Information SV = svenska 2009-10-13 2018-05-08
Clopidogrel ratiopharm GmbH : EPAR - Product Information SV = svenska 2009-10-13 2018-05-08
Clopidogrel ratiopharm GmbH : EPAR - Product Information SV = svenska 2009-10-13 2018-05-08
Clopidogrel ratiopharm GmbH : EPAR - Product Information SV = svenska 2009-10-13 2018-05-08
Clopidogrel ratiopharm GmbH : EPAR - Product Information SV = svenska 2009-10-13 2018-05-08
Clopidogrel ratiopharm GmbH : EPAR - Product Information SV = svenska 2009-10-13 2018-05-08
Clopidogrel ratiopharm GmbH : EPAR - Product Information SV = svenska 2009-10-13 2018-05-08
Clopidogrel ratiopharm GmbH : EPAR - Product Information SV = svenska 2009-10-13 2018-05-08
Clopidogrel ratiopharm GmbH : EPAR - Product Information SV = svenska 2009-10-13 2018-05-08
Clopidogrel ratiopharm GmbH : EPAR - Product Information SV = svenska 2009-10-13 2018-05-08
Clopidogrel ratiopharm GmbH : EPAR - Product Information SV = svenska 2009-10-13 2018-05-08
Clopidogrel ratiopharm GmbH : EPAR - Product Information SV = svenska 2009-10-13 2018-05-08
Clopidogrel ratiopharm GmbH : EPAR - Product Information SV = svenska 2009-10-13 2018-05-08
Clopidogrel ratiopharm GmbH : EPAR - Product Information SV = svenska 2009-10-13 2018-05-08
Clopidogrel ratiopharm GmbH : EPAR - Product Information SV = svenska 2009-10-13 2018-05-08
Clopidogrel ratiopharm GmbH : EPAR - Product Information SV = svenska 2009-10-13 2018-05-08
Clopidogrel ratiopharm GmbH : EPAR - Product Information SV = svenska 2009-10-13 2018-05-08
Clopidogrel ratiopharm GmbH : EPAR - Product Information SV = svenska 2009-10-13 2018-05-08

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 ratiopharm GmbH : EPAR - All Authorised presentations SV = svenska 2009-09-08 2011-03-31
Clopidogrel ratiopharm GmbH : EPAR - All Authorised presentations SV = svenska 2009-09-08 2011-03-31
Clopidogrel ratiopharm GmbH : EPAR - All Authorised presentations SV = svenska 2009-09-08 2011-03-31
Clopidogrel ratiopharm GmbH : EPAR - All Authorised presentations SV = svenska 2009-09-08 2011-03-31
Clopidogrel ratiopharm GmbH : EPAR - All Authorised presentations SV = svenska 2009-09-08 2011-03-31
Clopidogrel ratiopharm GmbH : EPAR - All Authorised presentations SV = svenska 2009-09-08 2011-03-31
Clopidogrel ratiopharm GmbH : EPAR - All Authorised presentations SV = svenska 2009-09-08 2011-03-31
Clopidogrel ratiopharm GmbH : EPAR - All Authorised presentations SV = svenska 2009-09-08 2011-03-31
Clopidogrel ratiopharm GmbH : EPAR - All Authorised presentations SV = svenska 2009-09-08 2011-03-31
Clopidogrel ratiopharm GmbH : EPAR - All Authorised presentations SV = svenska 2009-09-08 2011-03-31
Clopidogrel ratiopharm GmbH : EPAR - All Authorised presentations SV = svenska 2009-09-08 2011-03-31
Clopidogrel ratiopharm GmbH : EPAR - All Authorised presentations SV = svenska 2009-09-08 2011-03-31
Clopidogrel ratiopharm GmbH : EPAR - All Authorised presentations SV = svenska 2009-09-08 2011-03-31
Clopidogrel ratiopharm GmbH : EPAR - All Authorised presentations SV = svenska 2009-09-08 2011-03-31
Clopidogrel ratiopharm GmbH : EPAR - All Authorised presentations SV = svenska 2009-09-08 2011-03-31
Clopidogrel ratiopharm GmbH : EPAR - All Authorised presentations SV = svenska 2009-09-08 2011-03-31
Clopidogrel ratiopharm GmbH : EPAR - All Authorised presentations SV = svenska 2009-09-08 2011-03-31
Clopidogrel ratiopharm GmbH : EPAR - All Authorised presentations SV = svenska 2009-09-08 2011-03-31
Clopidogrel ratiopharm GmbH : EPAR - All Authorised presentations SV = svenska 2009-09-08 2011-03-31
Clopidogrel ratiopharm GmbH : EPAR - All Authorised presentations SV = svenska 2009-09-08 2011-03-31
Clopidogrel ratiopharm GmbH : EPAR - All Authorised presentations SV = svenska 2009-09-08 2011-03-31
Clopidogrel ratiopharm GmbH : EPAR - All Authorised presentations SV = svenska 2009-09-08 2011-03-31

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;
  • 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.

For further information please refer to section 5.1.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Clopidogrel ratiopharm GmbH : EPAR - Public assessment report SV = svenska 2009-09-08  
Summary of positive opinion for Clopidogrel Ratiopharm GmbH SV = svenska 2009-05-29  

Authorised

This medicine is approved for use in the European Union

More information on Clopidogrel Ratiopharm GmbH