OPSUMIT

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

Active ingredients

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

1 Macitentan UNII Z9K9Y9WMVL - MACITENTAN

Macitentan is an orally active potent endothelin receptor antagonist, active on both ETA and ETB receptors. Endothelin (ET)-1 and its receptors (ETA and ETB) mediate a variety of effects such as vasoconstriction, fibrosis, proliferation, hypertrophy, and inflammation. In disease conditions such as PAH, the local ET system is upregulated and is involved in vascular hypertrophy and in organ damage. Read about Macitentan

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
OPSUMIT 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
C02KX04		C Cardiovascular system → C02 Antihypertensives → C02K Other antihypertensives → C02KX Antihypertensives for pulmonary arterial hypertension
Discover more medicines within C02KX04

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): 10134J, 10136L, 12135Q, 12147H
Country: CA	Health Products and Food Branch	Identifier(s): 02415690
Country: DE	Bundesinstitut für Arzneimittel und Medizinprodukte	Identifier(s): 10131105
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 2788-MEE-0517, 5042-MEE-0320
Country: EE	Ravimiamet	Identifier(s): 1636590, 1636602, 1842285
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 113893002
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 493464
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 237058
Country: HK	Department of Health Drug Office	Identifier(s): 64419
Country: IE	Health Products Regulatory Authority	Identifier(s): 88038
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 7664
Country: IT	Agenzia del Farmaco	Identifier(s): 043174010, 043174022, 043174034
Country: JP	医薬品医療機器総合機構	Identifier(s): 2190035F1021
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1072544, 1072545, 1072546
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 115452
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 16347
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100312848
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W65300001
Country: SG	Health Sciences Authority	Identifier(s): 14809P
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699593095467
Country: US	FDA, National Drug Code	Identifier(s): 66215-501