VOLIBRIS

This brand name is authorized in Australia, Austria, Brazil, Canada, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Germany, Hong Kong SAR China, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Singapore, South Africa, Spain, Turkey, UK.

Active ingredients

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

1	Ambrisentan UNII HW6NV07QEC - AMBRISENTAN
	Ambrisentan is an orally active, propanoic acid-class, ERA selective for the endothelin A (ETA) receptor. Endothelin plays a significant role in the pathophysiology of PAH.
	Read more about Ambrisentan

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
VOLIBRIS Film-coated tablet	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
C02KX02	Ambrisentan	C Cardiovascular system → C02 Antihypertensives → C02K Other antihypertensives → C02KX Antihypertensives for pulmonary arterial hypertension
Discover more medicines within C02KX02

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	12180C, 12186J, 12201E, 12212R, 5607D, 5608E, 9648T, 9649W
BR	Câmara de Regulação do Mercado de Medicamentos	510612201111211, 510612202118211
CA	Health Products and Food Branch	02307065, 02307073
DE	Bundesinstitut für Arzneimittel und Medizinprodukte	00886110, 01467220
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	357-MEE-0614
EE	Ravimiamet	1349849, 1349850, 1349861, 1349872, 1863323, 1863334
ES	Centro de información online de medicamentos de la AEMPS	08451002, 08451004
FI	Lääkealan turvallisuus- ja kehittämiskeskus	119984, 120007
FR	Base de données publique des médicaments	66848183, 68499606
GB	Medicines & Healthcare Products Regulatory Agency	137558, 137563
HK	Department of Health Drug Office	63502, 63503
IE	Health Products Regulatory Authority	88517, 88518
IL	מִשְׂרַד הַבְּרִיאוּת	6242, 6243
IT	Agenzia del Farmaco	038528028, 038528042
JP	医薬品医療機器総合機構	2190031F1023
LT	Valstybinė vaistų kontrolės tarnyba	1032115, 1032116, 1032117, 1032118, 1093376
NL	Z-Index G-Standaard, PRK	86797, 86800
NZ	Medicines and Medical Devices Safety Authority	13875, 13876
PL	Rejestru Produktów Leczniczych	100192433, 100192456, 100461500
SG	Health Sciences Authority	15093P, 15094P
TR	İlaç ve Tıbbi Cihaz Kurumu	8699522091133, 8699522091164, 8699522091171, 8699522091263
ZA	Health Products Regulatory Authority	45/7.1.3/0106, 45/7.1.3/0107