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
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 more about Pirfenidone

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

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

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