Rivaroxaban STADA

Medicinal product

(Invented) name

Rivaroxaban STADA

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

STADA Arzneimittel AG, Vokietija

Date of authorisation

2022-11-08

Date of renewal

Documents

Rivaroxaban STADA mokomoji medziaga sveikatos prieziuros specialistams.pdf

5065_5069 Rivaroxaban STADA PCS PL 2023 09 22.docx

5069 Pakuotės lapelis gydymui pradeti 2023 09 22.docx

Rivaroxaban_Stada paciento_kortele.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

SE/H/2153/005/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje, skirtoje vartoti 1, 2 ir 3 savaitę, yra:	1 vnt.
Rivaroksabanas	15 mg
Tabletėje, skirtoje vartoti 4 savaitę 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
109817	95924	1095924	lizdinė plokštelė	N49 (N42x15 mg + N7x20 mg)		Receptinis	LT/1/22/5069/001	Tiekiama	-	-	No	-	-	Download
109818	95925	1095925	dalomoji lizdinė plokštelė	N49x1 (N(42 x1)x15 mg + N(7x1)x20 mg)		Receptinis	LT/1/22/5069/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-11-08	Registruotas