Prasugrel Mylan

prasugrel

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An overview of Prasugrel Mylan and why it is authorised in the EU

Prasugrel Mylan is taken together with aspirin to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries) in patients with acute coronary syndrome who are undergoing percutaneous coronary intervention. Acute coronary syndrome is a group of conditions in which blood supply in the vessels supplying the heart is interrupted so heart tissue cannot work properly or dies. It includes unstable angina (a severe type of chest pain) and heart attack. Percutaneous coronary intervention is a procedure used to unblock the blood vessels supplying the heart.

Prasugrel Mylan contains the active substance prasugrel and is a ‘generic medicine’. This means that Prasugrel Mylan contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Efient.

How is Prasugrel Mylan used?

Prasugrel Mylan is available as tablets (5 and 10 mg) and can only be obtained with a prescription. Prasugrel Mylan treatment starts with one 60-mg dose. This is then followed by 10 mg taken once a day, except in patients weighing less than 60 kg, who should take 5 mg once a day. Patients taking Prasugrel Mylan should also take aspirin as prescribed by their doctors. It is recommended that treatment with Prasugrel Mylan and aspirin continue for up to a year.

The use of Prasugrel Mylan is not recommended in patients over 75 years of age, unless the doctor has carefully considered its benefits and risks, and regards treatment with Prasugrel Mylan as necessary. In this case, the patient should take 5 mg daily following a 60-mg starting dose.

For more information about using Prasugrel Mylan, see the package leaflet or contact your doctor or pharmacist.

How does Prasugrel Mylan work?

The active substance in Prasugrel Mylan, prasugrel, is an inhibitor of platelet aggregation. This means that it helps to prevent blood clots from forming. Blood clots are caused by special cells in the blood, the platelets, sticking together (aggregating). Prasugrel stops the platelets aggregating by blocking a substance called ADP from binding to a receptor (target) on their surface. This stops the platelets becoming ‘sticky’, reducing the risk of a blood clot forming and helping to prevent a heart attack or a stroke.

How has Prasugrel Mylan been studied?

Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Efient, and do not need to be repeated for Prasugrel Mylan.

As for every medicine, the company provided studies on the quality of Prasugrel Mylan. The company also carried out studies that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

What are the benefits and risks of Prasugrel Mylan?

Because Prasugrel Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.

Why is Prasugrel Mylan authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, Prasugrel Mylan has been shown to have comparable quality and to be bioequivalent to Efient. Therefore, the Agency’s view was that, as for Efient, the benefit of Prasugrel Mylan outweighs the identified risk and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Prasugrel Mylan?

The company that markets Prasugrel Mylan will make sure that educational materials are available for doctors who will treat patients with the medicine. The materials will include information on how to prescribe the medicine safely and remind doctors that the medicine is not recommended for patients over the age of 75 years.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Prasugrel Mylan have also been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Prasugrel Mylan are continuously monitored. Side effects reported with Prasugrel Mylan are carefully evaluated and any necessary action taken to protect patients.

Other information about Prasugrel Mylan

Prasugrel Mylan received a marketing authorisation valid throughout the EU on 16 May 2018.

Name Language First published Last updated
Prasugrel Mylan : EPAR - Medicine overview BG = bălgarski 2018-05-24  
Prasugrel Mylan : EPAR - Medicine overview ES = español 2018-05-24  
Prasugrel Mylan : EPAR - Medicine overview CS = čeština 2018-05-24  
Prasugrel Mylan : EPAR - Medicine overview DA = dansk 2018-05-24  
Prasugrel Mylan : EPAR - Medicine overview DE = Deutsch 2018-05-24  
Prasugrel Mylan : EPAR - Medicine overview ET = eesti keel 2018-05-24  
Prasugrel Mylan : EPAR - Medicine overview EL = elliniká 2018-05-24  
Prasugrel Mylan : EPAR - Medicine overview EN = English 2018-05-24  
Prasugrel Mylan : EPAR - Medicine overview FR = français 2018-05-24  
Prasugrel Mylan : EPAR - Medicine overview IT = italiano 2018-05-24  
Prasugrel Mylan : EPAR - Medicine overview LV = latviešu valoda 2018-05-24  
Prasugrel Mylan : EPAR - Medicine overview LT = lietuvių kalba 2018-05-24  
Prasugrel Mylan : EPAR - Medicine overview HU = magyar 2018-05-24  
Prasugrel Mylan : EPAR - Medicine overview MT = Malti 2018-05-24  
Prasugrel Mylan : EPAR - Medicine overview NL = Nederlands 2018-05-24  
Prasugrel Mylan : EPAR - Medicine overview PL = polski 2018-05-24  
Prasugrel Mylan : EPAR - Medicine overview PT = português 2018-05-24  
Prasugrel Mylan : EPAR - Medicine overview RO = română 2018-05-24  
Prasugrel Mylan : EPAR - Medicine overview SK = slovenčina 2018-05-24  
Prasugrel Mylan : EPAR - Medicine overview SL = slovenščina 2018-05-24  
Prasugrel Mylan : EPAR - Medicine overview FI = suomi 2018-05-24  
Prasugrel Mylan : EPAR - Medicine overview SV = svenska 2018-05-24  
Prasugrel Mylan : EPAR - Medicine overview HR = Hrvatski 2018-05-24  
Name Language First published Last updated
Prasugrel Mylan : EPAR - Risk-management-plan summary (English only) 2018-06-18  

This EPAR was last updated on 18/06/2018 .

Authorisation details

Product details

Product details for Prasugrel Mylan
NamePrasugrel Mylan
Agency product numberEMEA/H/C/004644
Active substance

prasugrel besilate

International non-proprietary name (INN) or common name

prasugrel

Therapeutic area Angina, UnstableAcute Coronary SyndromeMyocardial Infarction
Anatomical therapeutic chemical (ATC) code B01AC22
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 Prasugrel Mylan
Marketing-authorisation holder

Mylan S.A.S

Revision1
Date of issue of marketing authorisation valid throughout the European Union16/05/2018

Contact address:

117 Allee des Parcs
69800 Saint-Priest
France

Product information

Product information

16/05/2018  Prasugrel Mylan -EMEA/H/C/004644 --

Name Language First published Last updated
Prasugrel Mylan : EPAR - Product Information EN = English 2018-05-24  
Prasugrel Mylan : EPAR - Product Information EN = English 2018-05-24  
Prasugrel Mylan : EPAR - Product Information EN = English 2018-05-24  
Prasugrel Mylan : EPAR - Product Information EN = English 2018-05-24  
Prasugrel Mylan : EPAR - Product Information EN = English 2018-05-24  
Prasugrel Mylan : EPAR - Product Information EN = English 2018-05-24  
Prasugrel Mylan : EPAR - Product Information EN = English 2018-05-24  
Prasugrel Mylan : EPAR - Product Information EN = English 2018-05-24  
Prasugrel Mylan : EPAR - Product Information EN = English 2018-05-24  
Prasugrel Mylan : EPAR - Product Information EN = English 2018-05-24  
Prasugrel Mylan : EPAR - Product Information EN = English 2018-05-24  
Prasugrel Mylan : EPAR - Product Information EN = English 2018-05-24  
Prasugrel Mylan : EPAR - Product Information EN = English 2018-05-24  
Prasugrel Mylan : EPAR - Product Information EN = English 2018-05-24  
Prasugrel Mylan : EPAR - Product Information EN = English 2018-05-24  
Prasugrel Mylan : EPAR - Product Information EN = English 2018-05-24  
Prasugrel Mylan : EPAR - Product Information EN = English 2018-05-24  
Prasugrel Mylan : EPAR - Product Information EN = English 2018-05-24  
Prasugrel Mylan : EPAR - Product Information EN = English 2018-05-24  
Prasugrel Mylan : EPAR - Product Information EN = English 2018-05-24  
Prasugrel Mylan : EPAR - Product Information EN = English 2018-05-24  
Prasugrel Mylan : EPAR - Product Information EN = English 2018-05-24  
Prasugrel Mylan : EPAR - Product Information EN = English 2018-05-24  
Prasugrel Mylan : EPAR - Product Information EN = English 2018-05-24  
Prasugrel Mylan : EPAR - Product Information EN = English 2018-05-24  

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
Prasugrel Mylan : EPAR - All Authorised presentations EN = English 2018-05-24  
Prasugrel Mylan : EPAR - All Authorised presentations EN = English 2018-05-24  
Prasugrel Mylan : EPAR - All Authorised presentations EN = English 2018-05-24  
Prasugrel Mylan : EPAR - All Authorised presentations EN = English 2018-05-24  
Prasugrel Mylan : EPAR - All Authorised presentations EN = English 2018-05-24  
Prasugrel Mylan : EPAR - All Authorised presentations EN = English 2018-05-24  
Prasugrel Mylan : EPAR - All Authorised presentations EN = English 2018-05-24  
Prasugrel Mylan : EPAR - All Authorised presentations EN = English 2018-05-24  
Prasugrel Mylan : EPAR - All Authorised presentations EN = English 2018-05-24  
Prasugrel Mylan : EPAR - All Authorised presentations EN = English 2018-05-24  
Prasugrel Mylan : EPAR - All Authorised presentations EN = English 2018-05-24  
Prasugrel Mylan : EPAR - All Authorised presentations EN = English 2018-05-24  
Prasugrel Mylan : EPAR - All Authorised presentations EN = English 2018-05-24  
Prasugrel Mylan : EPAR - All Authorised presentations EN = English 2018-05-24  
Prasugrel Mylan : EPAR - All Authorised presentations EN = English 2018-05-24  
Prasugrel Mylan : EPAR - All Authorised presentations EN = English 2018-05-24  
Prasugrel Mylan : EPAR - All Authorised presentations EN = English 2018-05-24  
Prasugrel Mylan : EPAR - All Authorised presentations EN = English 2018-05-24  
Prasugrel Mylan : EPAR - All Authorised presentations EN = English 2018-05-24  
Prasugrel Mylan : EPAR - All Authorised presentations EN = English 2018-05-24  
Prasugrel Mylan : EPAR - All Authorised presentations EN = English 2018-05-24  
Prasugrel Mylan : EPAR - All Authorised presentations EN = English 2018-05-24  
Prasugrel Mylan : EPAR - All Authorised presentations EN = English 2018-05-24  
Prasugrel Mylan : EPAR - All Authorised presentations EN = English 2018-05-24  
Prasugrel Mylan : EPAR - All Authorised presentations EN = English 2018-05-24  

Pharmacotherapeutic group

Antithrombotic agents

Therapeutic indication

Prasugrel Mylan, co administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with acute coronary syndrome (i.e. unstable angina, non-ST segment elevation myocardial infarction [UA/NSTEMI] or ST segment elevation myocardial infarction [STEMI]) undergoing primary or delayed percutaneous coronary intervention (PCI).

For further information please refer to section 5.1.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Prasugrel Mylan : EPAR - Public assessment report EN = English 2018-05-24  
CHMP summary of positive opinion for Prasugrel_Mylan EN = English 2018-03-23  

Authorised

This medicine is approved for use in the European Union

More information on Prasugrel Mylan