OFEV

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

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 more about Nintedanib

Medication package inserts

Below package inserts are available for further reading:

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