ROTEAS

This brand name is authorized in Austria, Brazil, Estonia, Croatia, Ireland, Lithuania, Poland, Romania

Active ingredients

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

1 Edoxaban UNII 32W99UE810 - EDOXABAN TOSYLATE

Edoxaban is a highly selective, direct and reversible inhibitor of factor Xa, the serine protease located in the final common pathway of the coagulation cascade. Edoxaban inhibits free factor Xa, and prothrombinase activity. Inhibition of factor Xa in the coagulation cascade reduces thrombin generation, prolongs clotting time and reduces the risk of thrombus formation. Read about Edoxaban

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
ROTEAS 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
B01AF03		B Blood and blood forming organs → B01 Antithrombotic agents → B01A Antithrombotic agents → B01AF Direct factor Xa inhibitors
Discover more medicines within B01AF03

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 530421070017703, 530421070017803, 530421070017903, 530421070018003, 530421070018103
Country: EE	Ravimiamet	Identifier(s): 1744107, 1744118, 1744129, 1744130, 1744141, 1744152, 1744163, 1744174, 1744185, 1744196, 1744208, 1744219, 1744220, 1744231, 1744242, 1744253, 1744264, 1744275, 1744286, 1744297, 1744309, 1744310, 1744321
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1082780, 1082781, 1083005, 1083006, 1083007, 1083008, 1083009, 1083010, 1083011, 1083012, 1083013, 1083014, 1083015, 1083016, 1083017, 1083018, 1083019, 1083020, 1083021, 1083022, 1083023, 1083024, 1083025, 1083026, 1083027, 1083028, 1083029, 1083030
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100388662, 100388679, 100388685
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W66573001, W66574001, W66575001