OPSUMIT

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

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 more about Macitentan

Medication package inserts

Below package inserts are available for further reading:

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