Rivaroxaban Olpha

Medicinal product

(Invented) name

Rivaroxaban Olpha

Active substance (s)

Rivaroksabanas

Strength

15 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

Olpha AS, Latvija

Date of authorisation

2025-06-10

Date of renewal

Documents

Rivaroxaban Olpha mokomoji medziaga sveikatos prieziuros specialistams.pdf

LT_0226_PubAR_SD+summary+LT apzvalga.pdf

Rivarox_Olpha_paciento_budrumo_kortele.docx

5802 Rivaroxaban Olpha 15mg PCS 2025 08 06.docx

5802-5803_pakuotes lapelis_2025-06-10.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

LT/H/0226/003/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Rivaroksabanas	15 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
117722	103826	1103826	lizdinė plokštelė	N28		Receptinis	LT/1/25/5802/001	Netiekiama	-	-	No	-	-
117723	103827	1103827	lizdinė plokštelė	N42		Receptinis	LT/1/25/5802/002	Netiekiama	-	-	No	-	-
117724	103828	1103828	lizdinė plokštelė	N98		Receptinis	LT/1/25/5802/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-06-10	Registruotas