Rivaroxaban Polpharma

Medicinal product

(Invented) name

Rivaroxaban Polpharma

Active substance (s)

Rivaroksabanas

Strength

20 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

5519_pakuotes lapelis_2024-07-29.docx

Rivaroxaban Polpharma paciento kortele.pdf

5519_Rivaroxaban Polpharma.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

LV/H/0261/003/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kapsulėje 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
114332	100443	1100443	lizdinė plokštelė	N14		Receptinis	LT/1/24/5519/001	Netiekiama	-	-	No	-	-
114333	100444	1100444	lizdinė plokštelė	N28		Receptinis	LT/1/24/5519/002	Tiekiama	-	-	No	-	-	Download
114334	100445	1100445	lizdinė plokštelė	N84		Receptinis	LT/1/24/5519/003	Netiekiama	-	-	No	-	-
114335	100446	1100446	lizdinė plokštelė	N98		Receptinis	LT/1/24/5519/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-07-29	Registruotas