TRACLEER

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

Active ingredients

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

1	Bosentan UNII Q326023R30 - BOSENTAN
	Bosentan is a dual endothelin receptor antagonist (ERA) with affinity for both endothelin A and B (ETA and ETB) receptors. Bosentan decreases both pulmonary and systemic vascular resistance resulting in increased cardiac output without increasing heart rate.
	Read more about Bosentan

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
TRACLEER 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
C02KX01	Bosentan	C Cardiovascular system → C02 Antihypertensives → C02K Other antihypertensives → C02KX Antihypertensives for pulmonary arterial hypertension
Discover more medicines within C02KX01

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	12134P, 12139X, 12140Y, 12143D, 12145F, 12146G, 12148J, 12149K, 5618Q, 5619R, 6429J, 6430K
CA	Health Products and Food Branch	02244981, 02244982
DE	Bundesinstitut für Arzneimittel und Medizinprodukte	02461596, 02461604, 12555335, 12555341, 16799904, 17437089
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	29443-11-10, 29466-11-10
EE	Ravimiamet	1207897, 1207909, 1207910, 1207921, 1207932, 1430637
ES	Centro de información online de medicamentos de la AEMPS	02220002, 02220004
FI	Lääkealan turvallisuus- ja kehittämiskeskus	010804, 010826
FR	Base de données publique des médicaments	61855918, 64186770, 65100183
GB	Medicines & Healthcare Products Regulatory Agency	47655, 47658
HK	Department of Health Drug Office	51759, 51760
IE	Health Products Regulatory Authority	88208, 88209
IL	מִשְׂרַד הַבְּרִיאוּת	4660, 4661
IT	Agenzia del Farmaco	035609027, 035609041, 035609078, 035609080
JP	医薬品医療機器総合機構	2190026F1022, 2190026X1028
LT	Valstybinė vaistų kontrolės tarnyba	1031309, 1031310, 1031311, 1031312, 1031313, 1050606, 1081751, 1081752
MX	Comisión Federal para la Protección contra Riesgos Sanitarios	096M2008
NL	Z-Index G-Standaard, PRK	67369, 67377, 93548
NZ	Medicines and Medical Devices Safety Authority	11549, 11550
PL	Rejestru Produktów Leczniczych	100111848, 100115504, 100315120
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W65304001, W65304002, W65304003, W65305001, W65305002
SG	Health Sciences Authority	12541P, 12543P
TN	Direction de la Pharmacie et du Médicament	16933011, 16933012
TR	İlaç ve Tıbbi Cihaz Kurumu	8697542090037, 8697542090044, 8699593095474, 8699593095481
US	FDA, National Drug Code	66215-101, 66215-102, 66215-103