Pirfenidone Viatris



This medicine is authorised for use in the European Union.


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.

This EPAR was last updated on 17/01/2023

Authorisation details

Product details
Pirfenidone Viatris
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
  • Idiopathic Pulmonary Fibrosis
  • Lung Diseases
  • Respiratory Tract Diseases
Anatomical therapeutic chemical (ATC) code

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
Contact address

Damastown Industrial Park 
Dublin 15 

Product information

10/01/2023 Pirfenidone Viatris - EMEA/H/C/005862 -

Other EU languages available 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:

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


Therapeutic indication

Pirfenidone Viatris is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF).

Assessment history

How useful was this page?

Add your rating