Leaflet ESBRIET 801mg film-coated tablets

Indicated for: idiopathic pulmonary fibrosis

Route of administration: oral

Substance: pirfenidone (antifibrotic agent)

ATC: L04AX05 (Antineoplastic and immunomodulating agents | 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 801mg

  • Substance: pirfenidone
  • Date of latest medicines list: 01-06-2026
  • Product code: W64379001
  • Concentration: 801mg
  • Pharmaceutical form: film-coated tablets
  • Quantity: 84
  • Product type: Original
  • Price: 8022.28 RON
  • 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: 667/2011/18
  • Shelf life: 2 years

Pharmaceutical forms available for pirfenidone

Concentrations available for pirfenidone

  • 267mg
  • 801mg
PDF icon EMA leaflet
Published: 11/03/2011
Updated: 08/05/2026

Compensation lists for ESBRIET 801mg Egis

NHP 6.20 (C2) - Idiopathic pulmonary fibrosis

Price

Copayment

Patient

8022.28 RON

8022.28 RON

0.00 RON