Rivaroxaban Polpharma

Medicinal product

(Invented) name

Rivaroxaban Polpharma

Active substance (s)

Rivaroksabanas

Strength

15 mg

Pharmaceutical form

kietosios kapsulės

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

Pharmaceutical Works POLPHARMA S.A., Lenkija

Date of authorisation

2024-07-29

Date of renewal

Documents

Rivaroxaban Polpharma mokomoji medziaga specialistams.pdf

5518_Rivaroxaban Polpharma.docx

5518_pakuotes lapelis_2024-07-29.docx

Rivaroxaban Polpharma paciento kortele.pdf

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

LV/H/0261/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kapsulėje 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
114327	100439	1100439	lizdinė plokštelė	N14		Receptinis	LT/1/24/5518/001	Netiekiama	-	-	No	-	-
114329	100440	1100440	lizdinė plokštelė	N28		Receptinis	LT/1/24/5518/002	Tiekiama	2025-03-13	-	No	-	-	Download
114330	100441	1100441	lizdinė plokštelė	N84		Receptinis	LT/1/24/5518/003	Netiekiama	-	-	No	-	-
114331	100442	1100442	lizdinė plokštelė	N98		Receptinis	LT/1/24/5518/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-07-29	Registruotas