VOLIBRIS

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

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 about Ambrisentan

Medication package inserts

Below package inserts are available for further reading:

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

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.