Leaflet ESBRIET 801mg film-coated tablets

Product code:
W64379001
Quantity:
84
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.

Official documents

Added to database:
11/03/2011
Source record updated:
08/05/2026

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

Compensation lists for ESBRIET 801mg Egis

NHP 6.20 (C2) - Idiopathic pulmonary fibrosis

Price
8022.28 RON
Copayment
8022.28 RON
Patient
0.00 RON