Prasugrel Mylan

RSS

prasugrel

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 15/10/2018

Authorisation details

Product details
Name
Prasugrel Mylan
Agency product number
EMEA/H/C/004644
Active substance
prasugrel besilate
International non-proprietary name (INN) or common name
prasugrel
Therapeutic area (MeSH)
  • Myocardial Infarction
  • Acute Coronary Syndrome
  • Angina, Unstable
Anatomical therapeutic chemical (ATC) code
B01AC22
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 medicines.

Publication details
Marketing-authorisation holder
Mylan S.A.S
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
16/05/2018
Contact address
117 Allee des Parcs
69800
Saint-Priest
France

Product information

03/09/2018 Prasugrel Mylan - EMEA/H/C/004644 - IB/0001/G

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.

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

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