Rivaroxaban Pharmazac

Medicinal product

(Invented) name

Rivaroxaban Pharmazac

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

Pharmazac S.A., Graikija

Date of authorisation

2026-01-06

Date of renewal

Documents

5934 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/3274/002/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

Tabletėje yra	1 mg
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
119552	105658	1105658	lizdinė plokštelė	N5		Receptinis	LT/1/25/5934/001	Netiekiama	-	-	No	-	-
119553	105659	1105659	lizdinė plokštelė	N10		Receptinis	LT/1/25/5934/002	Netiekiama	-	-	No	-	-
119554	105660	1105660	lizdinė plokštelė	N30		Receptinis	LT/1/25/5934/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2026-01-06	Registruotas