Pirfenidone axunio (previously Pirfenidone AET)

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pirfenidone

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

Overview

Pirfenidone axunio is a medicine 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 AET is a ‘generic medicine’. This means that Pirfenidone AET 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 AET contains the active substance pirfenidone.

This EPAR was last updated on 12/10/2022

Authorisation details

Product details
Name
Pirfenidone axunio (previously Pirfenidone AET)
Agency product number
EMEA/H/C/005873
Active substance
Pirfenidone
International non-proprietary name (INN) or common name
pirfenidone
Therapeutic area (MeSH)
Idiopathic Pulmonary Fibrosis
Anatomical therapeutic chemical (ATC) code
L04AX05
GenericGeneric

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
Axunio Pharma GmbH
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
20/06/2022
Contact address

Van-der-Smissen-Straße 1
22767 Hamburg
Germany

Product information

07/10/2022 Pirfenidone axunio (previously Pirfenidone AET) - EMEA/H/C/005873 - T/0001

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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

Immunosuppressants

Therapeutic indication

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

Assessment history

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