ROTEAS

This brand name is authorized in Austria, Brazil, Croatia, Estonia, 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 more about Edoxaban

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
ROTEAS 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
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)
BR	Câmara de Regulação do Mercado de Medicamentos	530421070017703, 530421070017803, 530421070017903, 530421070018003, 530421070018103
EE	Ravimiamet	1744107, 1744118, 1744129, 1744130, 1744141, 1744152, 1744163, 1744174, 1744185, 1744196, 1744208, 1744219, 1744220, 1744231, 1744242, 1744253, 1744264, 1744275, 1744286, 1744297, 1744309, 1744310, 1744321
LT	Valstybinė vaistų kontrolės tarnyba	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
PL	Rejestru Produktów Leczniczych	100388662, 100388679, 100388685
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W66573001, W66574001, W66575001