PRADAXA

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

Active ingredients

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

1 Dabigatran UNII SC7NUW5IIT - DABIGATRAN ETEXILATE MESYLATE

Dabigatran etexilate is a small molecule prodrug which does not exhibit any pharmacological activity. After oral administration, dabigatran etexilate is rapidly absorbed and converted to dabigatran by esterase-catalysed hydrolysis in plasma and in the liver. Dabigatran is a potent, competitive, reversible direct thrombin inhibitor and is the main active principle in plasma. Read about Dabigatran

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
PRADAXA 75mg Hard capsule	European Medicines Agency (EU)	MPI, EU: SmPC
PRADAXA Coated granules	European Medicines Agency (EU)	MPI, EU: SmPC
PRADAXA 110mg Hard capsule	European Medicines Agency (EU)	MPI, EU: SmPC
PRADAXA 150mg Hard capsule	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
B01AE07	Dabigatran etexilate	B Blood and blood forming organs → B01 Antithrombotic agents → B01A Antithrombotic agents → B01AE Direct thrombin inhibitors
Discover more medicines within B01AE07

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): 2753X, 2769R, 9318K, 9319L, 9320M, 9321N, 9322P, 9323Q
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 504505101119316, 504505102115314, 504505103111312, 504505104118310, 504505105114319, 504505106110317, 504505107117315, 504505108113313
Country: CA	Health Products and Food Branch	Identifier(s): 02312433, 02312441, 02358808
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 28863-05-09, 28864-05-09, 30190-05-12
Country: EE	Ravimiamet	Identifier(s): 1343359, 1343360, 1343371, 1343382, 1343393, 1343405, 1538726, 1538737, 1538748, 1538759, 1538760, 1587258, 1587269
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 08442002, 08442003, 08442005, 08442006, 08442007, 08442011
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 115330, 115341, 115364, 442705
Country: FR	Base de données publique des médicaments	Identifier(s): 63484283, 65570603, 65693901
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 135048, 135051, 135055, 135056, 194659, 368206, 368212, 375293, 375296
Country: HK	Department of Health Drug Office	Identifier(s): 57315, 57316, 60516
Country: IE	Health Products Regulatory Authority	Identifier(s): 36882, 36883, 60602, 60603, 60612, 60615, 60616, 60617, 60628, 60633, 60634, 60659, 60681, 60684, 60685
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 6317, 6318, 6319, 6320, 6321, 6685
Country: IT	Agenzia del Farmaco	Identifier(s): 038451011, 038451023, 038451035, 038451047, 038451062, 038451074, 038451086, 038451098, 038451100, 038451112, 038451124, 038451136, 038451148, 038451201, 038451213, 038451225, 038451237, 038451249, 038451252, 038451264
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1031768, 1031769, 1031770, 1031771, 1031772, 1031773, 1031774, 1031775, 1061808, 1061809, 1061810, 1061811, 1061812, 1061815, 1067398, 1067399, 1067400, 1067401, 1067402, 1091757, 1091758, 1091759, 1091760, 1091761, 1091762, 1091763
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 86983, 86991, 98361
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 13118, 13119, 14318
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100191706, 100191712, 100250679, 100455414, 100455421, 100455446, 100455453, 100455460, 100455478, 100455485
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W52942001, W52942002, W52942003, W52942004, W52943001, W52943002, W52943003, W52943004, W52943005, W57151001, W57151002, W57151003, W57151004, W57151005, W69037001, W69038001, W69039001, W69040001, W69041001, W69042001, W69043001
Country: SG	Health Sciences Authority	Identifier(s): 13697P, 13698P, 13941P
Country: TN	Direction de la Pharmacie et du Médicament	Identifier(s): 11533041, 11533042, 11533043
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699693150042, 8699693150059, 8699693150097, 8699693150103, 8699693150127
Country: US	FDA, National Drug Code	Identifier(s): 0597-0108, 0597-0355, 0597-0360, 50090-3617, 50090-4480, 63629-8242
Country: ZA	Health Products Regulatory Authority	Identifier(s): 42/8.2/0130, 42/8.2/0131, 45/8.2/0162