TRACLEER

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

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 about Bosentan

Medication package inserts

Below package inserts are available for further reading:

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