Rivaroxaban Olpha

Medicinal product

(Invented) name

Rivaroxaban Olpha

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

Olpha AS, Latvija

Date of authorisation

2025-06-10

Date of renewal

Documents

LT_0226_PubAR_SD+summary+LT apzvalga.pdf

5800_pakuotes lapelis_2025-06-10.docx

5800 Rivaroxaban Olpha 2,5mg PCS 2025 08 06.docx

Rivaroxaban Olpha mokomoji medziaga farmacijos specialistams_Laiskas farmacininkams.pdf

Rivaroxaban Olpha mokomoji medziaga sveikatos prieziuros specialistams.pdf

Rivarox_Olpha_paciento_budrumo_kortele.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

LT/H/0226/001/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
117718	103822	1103822	lizdinė plokštelė	N56		Receptinis	LT/1/25/5800/001	Netiekiama	-	-	No	-	-
117719	103823	1103823	lizdinė plokštelė	N196		Receptinis	LT/1/25/5800/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-06-10	Registruotas