Xarelto

Medicinal product

(Invented) name

Xarelto

Active substance (s)

Rivaroksabanas+Rivaroksabanas

Strength

15 mg + 20 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

B01AF01, Rivaroxaban

Marketing authorisation holder

Bayer AG, Vokietija

Date of authorisation

2008-09-30

Date of renewal

Documents

Xarelto paciento kortele.pdf

Xarelto mokomoji medziaga sveikatos prieziuros specialistams.pdf

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

15 mg film-coated tablet	1 vnt.
Rivaroksabanas	15 mg
20 mg film-coated tablet	1 vnt.
Rivaroksabanas	20 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
68573	83153	1083153	lizdinė plokštelė	N49 (42x15 mg + 7x20 mg)		Receptinis	EU/1/08/472/040	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2008-09-30	Registruotas