Xiltess

Medicinal product

(Invented) name

Xiltess

Active substance (s)

Rivaroksabanas

Strength

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

Egis Pharmaceuticals PLC, Vengrija

Date of authorisation

2023-01-20

Date of renewal

Documents

5105 Xiltess 20mg PCS PL 2023 10 10.docx

Xiltess mokomoji medziaga sveikatos prieziuros specialistams.pdf

Xiltess_paciento_BK.docx

5104_5105 Pakuotės lapelis 15mg,20mg 2023 10 10.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/5431/004/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra:	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
110236	96345	1096345	lizdinė plokštelė	N28		Receptinis	LT/1/23/5105/001	Netiekiama	-	-	No	-	-
110237	96346	1096346	lizdinė plokštelė	N98		Receptinis	LT/1/23/5105/002	Netiekiama	-	-	No	-	-
110238	96347	1096347	lizdinė plokštelė	N100		Receptinis	LT/1/23/5105/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-01-20	Registruotas