Rivaroxaban Pharmazac

Medicinal product

(Invented) name

Rivaroxaban Pharmazac

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

Pharmazac S.A., Graikija

Date of authorisation

2026-01-06

Date of renewal

Documents

5933 Pakuotės lapelis 2026 01 27.docx

5933_5936 Rivaroxaban Pharmazac RPP 2026 01 27.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DK/H/3274/001/E/001

Marketing authorisation procedure

Kartotinė 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
119545	105651	1105651	lizdinė plokštelė	N10		Receptinis	LT/1/25/5933/001	Netiekiama	-	-	No	-	-
119546	105652	1105652	lizdinė plokštelė	N14		Receptinis	LT/1/25/5933/002	Netiekiama	-	-	No	-	-
119547	105653	1105653	lizdinė plokštelė	N56		Receptinis	LT/1/25/5933/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2026-01-06	Registruotas