ESBRIET

This brand name is authorized in Austria, Australia, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa

Active ingredients

The drug ESBRIET contains one active pharmaceutical ingredient (API):

1 Pirfenidone UNII D7NLD2JX7U - PIRFENIDONE

Pirfenidone attenuates fibroblast proliferation, production of fibrosis-associated proteins and cytokines, and the increased biosynthesis and accumulation of extracellular matrix in response to cytokine growth factors. Pirfenidone is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF). Read about Pirfenidone

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
ESBRIET Hard capsule	European Medicines Agency (EU)	MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code	Group title	Classification
L04AX05	Pirfenidone	L Antineoplastic and immunomodulating agents → L04 Immunosuppressants → L04A Immunosuppressants → L04AX Other immunosuppressants
Discover more medicines within L04AX05

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
Country: AU	Pharmaceutical Benefits Scheme	Identifier(s): 11136D, 11406H, 11410M
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 529216090026702
Country: CA	Health Products and Food Branch	Identifier(s): 02393751, 02464489, 02464500
Country: EE	Ravimiamet	Identifier(s): 1518870, 1518881, 1518892, 1744332, 1744343, 1744354, 1744365, 1744387, 1750801, 1750812, 1750823, 1750834, 1750845, 1750856, 1750867, 1761487
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 111667016, 111667018
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 383837, 446921, 559816
Country: FR	Base de données publique des médicaments	Identifier(s): 66527665, 66673182
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 346226, 346233, 346238
Country: HK	Department of Health Drug Office	Identifier(s): 64288, 67135, 67136
Country: IE	Health Products Regulatory Authority	Identifier(s): 88389, 88864, 88869, 89001
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 8450, 8486
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1059260, 1059261, 1059262, 1083132, 1083133, 1083134, 1083135, 1083136, 1083137, 1083138, 1083219, 1083220, 1083221, 1083222, 1083223, 1083224, 1083235, 1083236, 1085551, 1085552
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 107387, 146765, 146773
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 17627, 18789, 18790, 18791
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100299639, 100388260, 100388277, 100388283
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W64377001, W64378001, W64379001
Country: SG	Health Sciences Authority	Identifier(s): 15124P, 15600P, 15601P
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699505091228, 8699505091235
Country: US	FDA, National Drug Code	Identifier(s): 50242-121, 50242-122, 50242-123
Country: ZA	Health Products Regulatory Authority	Identifier(s): 50/32.16/1168