Apixaban Olpha

Medicinal product

(Invented) name

Apixaban Olpha

Active substance (s)

Apiksabanas

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)

B01AF02, Apixaban

Marketing authorisation holder

Olpha AS, Latvija

Date of authorisation

2024-09-25

Date of renewal

Documents

5589-5590 Apixaban Olpha.docx

5589-pakuotes lapelis_2024-09-25.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

LV/H/0267/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra:	1 vnt.
Apiksabanas	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
115119	101229	1101229	lizdinė plokštelė	N20		Receptinis	LT/1/24/5589/001	Netiekiama	-	-	No	-	-
115120	101230	1101230	lizdinė plokštelė	N60		Receptinis	LT/1/24/5589/002	Netiekiama	-	-	No	-	-
115121	101231	1101231	lizdinė plokštelė	N168		Receptinis	LT/1/24/5589/003	Netiekiama	-	-	No	-	-
115122	101232	1101232	buteliukas	N200		Receptinis	LT/1/24/5589/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-09-25	Registruotas