Medicine information ESBRIET 267mg capsules

Product code:
W64377001
Quantity:
63
Indicated for:
idiopathic pulmonary fibrosis
Route of administration:
oral
Substance:
pirfenidone (antifibrotic agent)
ATC
L04AX05 — Antineoplastic and immunomodulating agents | Immunosuppressants | Immunosuppressants | Other immunosuppressants

Pirfenidone is a medication used for the treatment of idiopathic pulmonary fibrosis (IPF), a chronic progressive disease affecting the lungs.
It works by reducing inflammation and the formation of scar tissue in the lungs, thereby slowing the progression of the disease.

Pirfenidone is administered as oral tablets, usually three times a day, with the dose gradually increased to minimize the risk of side effects.
The medication helps improve lung function and reduce symptoms such as shortness of breath and fatigue.

Common side effects include nausea, diarrhea, skin rashes, and increased sensitivity to sunlight.
Patients should avoid prolonged sun exposure and use sunscreen to prevent skin reactions.

It is important for patients to undergo regular liver function tests during treatment, as pirfenidone may affect the liver.
The medication is not recommended for pregnant or breastfeeding women without medical consultation.

General data about ESBRIET 267mg

Substance:
pirfenidone
Date of latest medicines list:
01-03-2022
Product code:
W64377001
Strength:
267mg
Pharmaceutical form:
capsules
Quantity:
63
Product type:
Original
Prescription status:
P-RF — Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

Manufacturer:
ROCHE PHARMA AG - GERMANIA
Holder:
ROCHE REGISTRATION GMBH - GERMANIA
Number:
667/2011/01
Shelf life:
4 years

Pharmaceutical forms available for pirfenidone

Strengths available for pirfenidone

  • 267mg
  • 801mg

Official documents

The SmPC text is not displayed because a match to this medicine, strength and pharmaceutical form has not been confirmed.

The correspondence between the document and the displayed text is unconfirmed.

Source institution
EMA
Document language
English
Source record: first published
11/03/2011
Source record: last updated
10/07/2026