Esbriet 801 mg film-coated tablets

Licence holder

Roche Registration Limited (all products →)

Active substance

Pirfenidone

Dosage form

Film-coated tablet

Route of administration

Oral use

ATC code

L04AX05

First authorised

24/04/2017

Prescription status

Product subject to prescription which may not be renewed (A)

Supply

Supply through pharmacies only

Legal basis

Full application (Article 8(3) of Directive No 2001/83/EC)

This listing is regulatory information, not medical advice — consult the package leaflet, SPC, or a healthcare professional. For the authoritative record see the HPRA register.