Rivaroxaban Farmak

Medicinal product

(Invented) name

Rivaroxaban Farmak

Active substance (s)

Rivaroksabanas

Strength

10 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

Farmak International Sp. z o.o., Lenkija

Date of authorisation

2022-12-29

Date of renewal

Documents

Rivaroxaban Farmak_paciento kortele.docx

LT_0175_RIVAROXABAN_FARMAK_AR_SD+apzvalga.pdf

5087_5090 Rivaroxaban Farmak RPP 2025 05 16.docx

5088 Pakuotės lapelis 2025 05 16.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

LT/H/0175/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje 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
110041	96150	1096150	lizdinė plokštelė	N10		Receptinis	LT/1/22/5088/001	Netiekiama	-	-	No	-	-
110042	96151	1096151	lizdinė plokštelė	N98		Receptinis	LT/1/22/5088/002	Netiekiama	-	-	No	-	-
110043	96152	1096152	lizdinė plokštelė	N100		Receptinis	LT/1/22/5088/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-12-29	Registruotas