Rivaroxaban Auxilia

Medicinal product

(Invented) name

Rivaroxaban Auxilia

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

Auxilia Pharma OÜ, Estija

Date of authorisation

2021-02-10

Date of renewal

Documents

4672 Pakuotės lapelis gydymui pradeti 2024 03 06.docx

4668_4672 Rivaroxaban Auxilia PCS PL 2024 03 06.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

LV/H/0216/003-004

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje (15 mg) yra:	1 vnt.
Rivaroksabanas	15 mg
Tabletėje (20 mg) 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
105815	91915	1091915	lizdinė plokštelė	N49 (N42 (15 mg) + N7 (20 mg))	pakuotė gydymui pradėti	Receptinis	LT/1/21/4672/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-02-10	Registruotas