Apixaban Zentiva k.s.

Medicinal product

(Invented) name

Apixaban Zentiva k.s.

Active substance (s)

Apiksabanas

Strength

1,25 mg/ml

Pharmaceutical form

geriamoji suspensija

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

B01AF02, Apixaban

Marketing authorisation holder

Zentiva k.s., Čekija

Date of authorisation

2026-05-13

Date of renewal

Documents

6020_pakuotes lapelis_2026-05-13.docx

6020_Apixaban Zentiva ks.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

MT/H/0687/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml suspensijos yra	1 ml
Apiksabanas	1,25 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
120815	106923	1106923	buteliukas	75 ml N1 (5 ml geriamasis švirkštas)		Receptinis	LT/1/26/6020/001	Netiekiama	-	-	No	-	-
120816	106924	1106924	buteliukas	100 ml N1 (5 ml geriamasis švirkštas)		Receptinis	LT/1/26/6020/002	Netiekiama	-	-	No	-	-
120817	106925	1106925	buteliukas	150 ml N1 (5 ml geriamasis švirkštas)		Receptinis	LT/1/26/6020/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2026-05-13	Registruotas