Mibrex

Medicinal product

(Invented) name

Mibrex

Active substance (s)

Rivaroksabanas+Rivaroksabanas

Strength

15 mg + 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

Zakłady Farmaceutyczne POLPHARMA S.A., Lenkija

Date of authorisation

2020-04-29

Date of renewal

2024-08-09

Documents

4552_Mibrex _perr2024-09-08.docx

4552_pakuotes lapelis_2024-09-08.docx

Mibrex mokomoji medziaga sveikatos prieziuros specialistams.pdf

Mibrex paciento kortele.pdf

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

PL/H/0523/005/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Rausvoje tabletėje ("15") yra:	1 vnt.
Rivaroksabanas	15 mg
Rusvai raudonoje tabletėje ("20") 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
103876	89978	1089978	lizdinė plokštelė	N49 (N42×15 mg + N7×20 mg)		Receptinis	LT/1/20/4552/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-08-09	Perregistruotas
2020-04-29	Registruotas