Rivaroxaban Pharmazac

Medicinal product

(Invented) name

Rivaroxaban Pharmazac

Active substance (s)

Rivaroksabanas

Strength

20 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

5935_5936 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/3274/004/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

Tabletėje 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
119558	105664	1105664	lizdinė plokštelė	N10		Receptinis	LT/1/25/5936/001	Netiekiama	-	-	No	-	-
119559	105665	1105665	lizdinė plokštelė	N14		Receptinis	LT/1/25/5936/002	Netiekiama	-	-	No	-	-
119560	105666	1105666	lizdinė plokštelė	N28		Receptinis	LT/1/25/5936/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2026-01-06	Registruotas