Prasugrel Mylan
prasugrel
Table of contents
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.
-
List item
Prasugrel Mylan : EPAR - Medicine overview (PDF/87.46 KB)
First published: 24/05/2018
Last updated: 24/05/2018
EMA/203583/2018 -
-
List item
Prasugrel Mylan : EPAR - Risk-management-plan summary (PDF/82.22 KB)
First published: 18/06/2018
Last updated: 18/06/2018
EMA/243819/2018
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) |
|
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 and hybrid medicines. |
Publication details | |
---|---|
Marketing-authorisation holder |
Mylan Pharmaceuticals Limited
|
Revision |
8
|
Date of issue of marketing authorisation valid throughout the European Union |
15/05/2018
|
Contact address |
Mylan Pharmaceuticals Limited |
Product information
25/05/2022 Prasugrel Mylan - EMEA/H/C/004644 - N/0010
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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).