Rivaroxaban Polpharma

Medicinal product

(Invented) name

Rivaroxaban Polpharma

Active substance (s)

Rivaroksabanas

Strength

10 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

Zakłady Farmaceutyczne POLPHARMA S.A., Lenkija

Date of authorisation

2024-07-29

Date of renewal

Documents

Rivaroxaban Polpharma paciento kortele.pdf

5517_Rivaroxaban Polpharma.docx

Rivaroxaban Polpharma mokomoji medziaga specialistams.pdf

5517_pakuotes lapelis_2024-07-29.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

LV/H/0261/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kapsulėje yra:	1 vnt.
Rivaroksabanas	10 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
114326	100438	1100438	lizdinė plokštelė	N10		Receptinis	LT/1/24/5517/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-07-29	Registruotas