OFEV

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

Active ingredients

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

1 Nintedanib UNII 42F62RTZ4G - NINTEDANIB ESYLATE

Nintedanib is a triple angiokinase inhibitor blocking vascular endothelial growth factor receptors (VEGFR 1-3), platelet-derived growth factor receptors (PDGFR α and β) and fibroblast growth factor receptors (FGFR 1-3) kinase activity. Nintedanib binds competitively to the adenosine triphosphate (ATP) binding pocket of these receptors and blocks the intracellular signalling which is crucial for the proliferation and survival of endothelial as well as perivascular cells (pericytes and vascular smooth muscle cells). Read about Nintedanib

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
OFEV Soft 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
L01EX09		L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01E Protein kinase inhibitors → L01EX Other protein kinase inhibitors
Discover more medicines within L01EX09

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): 11100F, 11106M
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 504516020020201, 504516020020301
Country: CA	Health Products and Food Branch	Identifier(s): 02443066, 02443074
Country: EE	Ravimiamet	Identifier(s): 1675560, 1675571, 1675582, 1675593
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 114979002, 114979004
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 197927, 484271
Country: FR	Base de données publique des médicaments	Identifier(s): 62388307, 62960765
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 307685, 307689
Country: HK	Department of Health Drug Office	Identifier(s): 64604, 64605
Country: IE	Health Products Regulatory Authority	Identifier(s): 88795, 88796
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 7619, 7620
Country: IT	Agenzia del Farmaco	Identifier(s): 043827017, 043827029, 043827031, 043827043
Country: JP	医薬品医療機器総合機構	Identifier(s): 3999039M1022, 3999039M2029
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1075449, 1075450, 1075451, 1075452
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 127310, 127329
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 17259, 17260
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100335542, 100335559
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W61689001, W61689002, W61690001, W61690002
Country: SG	Health Sciences Authority	Identifier(s): 14921P, 14922P
Country: TN	Direction de la Pharmacie et du Médicament	Identifier(s): 1153311H, 1153312H
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699693190079, 8699693190093
Country: US	FDA, National Drug Code	Identifier(s): 0597-0143, 0597-0145