Pirfenidone Viatris
pirfenidone
Table of contents
Overview
Pirfenidone Viatris is used to treat adults with mild to moderate idiopathic pulmonary fibrosis (IPF). IPF is a long-term disease in which fibrous scar tissue continuously forms in the lungs, causing persistent cough, frequent lung infections and severe shortness of breath. ‘Idiopathic’ means that the cause of the disease is unknown.
Pirfenidone Viatris is a ‘generic medicine’. This means that it contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Esbriet. For more information on generic medicines, see the question-and-answer document here.
Pirfenidone Viatris contains the active substance pirfenidone.
-
List item
Pirfenidone Viatris : EPAR - Medicine overview (PDF/119 KB)
First published: 17/01/2023
EMA/888890/2022 -
-
List item
Pirfenidone Viatris : EPAR - Risk Management Plan (PDF/110.59 KB)
First published: 17/01/2023
Authorisation details
Product details | |
---|---|
Name |
Pirfenidone Viatris
|
Agency product number |
EMEA/H/C/005862
|
Active substance |
Pirfenidone
|
International non-proprietary name (INN) or common name |
pirfenidone
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
L04AX05
|
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 |
Viatris Limited
|
Date of issue of marketing authorisation valid throughout the European Union |
10/01/2023
|
Contact address |
Damastown Industrial Park |
Product information
10/01/2023 Pirfenidone Viatris - EMEA/H/C/005862 -
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
Immunosuppressants
Therapeutic indication
Pirfenidone Viatris is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF).