Overview

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis for the CHMP recommendations, read the scientific discussion (also part of the EPAR).

Zyllt is a medicine that contains the active substance clopidogrel. It is available as pink, round tablets (75 mg).

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

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

  • patients who have recently had a myocardial infarction (heart attack). Zyllt 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). Zyllt 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). Zyllt 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.

The standard dose of Zyllt is one 75 mg tablet once a day, taken with or without food. In acute coronary syndrome, Zyllt 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).

The active substance in Zyllt, 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.

Because Zyllt is a generic medicine, studies 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.

Because Zyllt is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.

The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Zyllt 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 Zyllt be given marketing authorisation.

The European Commission granted a marketing authorisation valid throughout the EU for Zyllt to Krka, d.d., Novo mesto on 28 September 2009.

Zyllt : EPAR - Summary for the public

български (BG) (167.91 KB - PDF)
español (ES) (45.02 KB - PDF)
čeština (CS) (159.75 KB - PDF)
dansk (DA) (44.7 KB - PDF)
Deutsch (DE) (45.6 KB - PDF)
eesti keel (ET) (44.42 KB - PDF)
ελληνικά (EL) (177.51 KB - PDF)
français (FR) (45.29 KB - PDF)
italiano (IT) (44.79 KB - PDF)
latviešu valoda (LV) (155.42 KB - PDF)
lietuvių kalba (LT) (153.58 KB - PDF)
magyar (HU) (117.42 KB - PDF)
Malti (MT) (159.63 KB - PDF)
Nederlands (NL) (44.83 KB - PDF)
polski (PL) (164.37 KB - PDF)
português (PT) (45.24 KB - PDF)
română (RO) (149.58 KB - PDF)
slovenčina (SK) (153.65 KB - PDF)
slovenščina (SL) (114.86 KB - PDF)
Suomi (FI) (44.41 KB - PDF)
svenska (SV) (44.55 KB - PDF)

Product information

Zyllt : EPAR - Product Information

български (BG) (313.25 KB - PDF)
español (ES) (369.66 KB - PDF)
čeština (CS) (280.78 KB - PDF)
dansk (DA) (292.63 KB - PDF)
Deutsch (DE) (292 KB - PDF)
eesti keel (ET) (266.32 KB - PDF)
ελληνικά (EL) (326.02 KB - PDF)
français (FR) (301.7 KB - PDF)
hrvatski (HR) (279.52 KB - PDF)
íslenska (IS) (280.16 KB - PDF)
italiano (IT) (284.97 KB - PDF)
latviešu valoda (LV) (275.73 KB - PDF)
lietuvių kalba (LT) (291.31 KB - PDF)
magyar (HU) (313.85 KB - PDF)
Malti (MT) (328.92 KB - PDF)
Nederlands (NL) (273.65 KB - PDF)
norsk (NO) (282.07 KB - PDF)
polski (PL) (302.92 KB - PDF)
português (PT) (275.14 KB - PDF)
română (RO) (285.01 KB - PDF)
slovenčina (SK) (282.57 KB - PDF)
slovenščina (SL) (293.04 KB - PDF)
Suomi (FI) (275.69 KB - PDF)
svenska (SV) (270.92 KB - PDF)

Latest procedure affecting product information: IB/0045/G

25/12/2024

Globe icon

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).

Zyllt : EPAR - All Authorised presentations

български (BG) (79.47 KB - PDF)
español (ES) (30.89 KB - PDF)
čeština (CS) (44.37 KB - PDF)
dansk (DA) (14.8 KB - PDF)
Deutsch (DE) (30.57 KB - PDF)
eesti keel (ET) (16.09 KB - PDF)
ελληνικά (EL) (77.77 KB - PDF)
français (FR) (16.12 KB - PDF)
hrvatski (HR) (129.17 KB - PDF)
íslenska (IS) (55.91 KB - PDF)
italiano (IT) (14.71 KB - PDF)
latviešu valoda (LV) (82.1 KB - PDF)
lietuvių kalba (LT) (84.54 KB - PDF)
magyar (HU) (82.68 KB - PDF)
Malti (MT) (79.66 KB - PDF)
Nederlands (NL) (15.38 KB - PDF)
norsk (NO) (52.87 KB - PDF)
polski (PL) (46.26 KB - PDF)
português (PT) (15.91 KB - PDF)
română (RO) (79.46 KB - PDF)
slovenčina (SK) (44.99 KB - PDF)
slovenščina (SL) (14.89 KB - PDF)
Suomi (FI) (15.9 KB - PDF)
svenska (SV) (15.21 KB - PDF)

Product details

Name of medicine
Zyllt
Active substance
clopidogrel (as hydrogen sulfate)
International non-proprietary name (INN) or common name
clopidogrel
Therapeutic area (MeSH)
  • Peripheral Vascular Diseases
  • Stroke
  • Acute Coronary Syndrome
  • Myocardial Infarction
Anatomical therapeutic chemical (ATC) code
B01AC04

Pharmacotherapeutic group

Antithrombotic agents

Therapeutic indication

Prevention Secondary prevention of atherothrombotic events Clopidogrel is indicated in:

  • Adult 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.
  • Adult 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.

  • Prevention of atherothrombotic and thromboembolic events in atrial fibrillation:

- In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with Vitamin K antagonists (VKA) and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.

Authorisation details

EMA product number
EMEA/H/C/001058

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
Krka, d.d., Novo mesto

KRKA d.d., Novo mesto
Šmarješka cesta 6
SI-8501 Novo mesto
Slovenia

Marketing authorisation issued
28/09/2009
Revision
17

Assessment history

Zyllt : EPAR - Procedural steps taken and scientific information after authorisation

Zyllt : EPAR - Public assessment report

Committee for medicinal products for human use summary of positive opinion for Zyllt

This page was last updated on

How useful do you find this page?