Xiltess

Medicinal product

(Invented) name

Xiltess

Active substance (s)

Rivaroksabanas

Strength

2,5 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

Xiltess mokomoji medziaga sveikatos prieziuros specialistams.pdf

5102 Pakuotės lapelis 2023 10 10.docx

Xiltess_paciento_BK.docx

5102 Xiltess 2,5mg PCS PL 2023 10 10.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/5431/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra:	1 vnt.
Rivaroksabanas	2,5 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
110224	96333	1096333	lizdinė plokštelė	N56		Receptinis	LT/1/23/5102/001	Tiekiama	-	-	No	-	-
110225	96334	1096334	lizdinė plokštelė	N98		Receptinis	LT/1/23/5102/002	Netiekiama	-	-	No	-	-
110226	96335	1096335	lizdinė plokštelė	N100		Receptinis	LT/1/23/5102/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-01-20	Registruotas