Apixaban Olpha

Medicinal product

(Invented) name

Apixaban Olpha

Active substance (s)

Apiksabanas

Strength

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

5590-pakuotes lapelis_2024-09-25.docx

5589-5590 Apixaban Olpha.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

LV/H/0267/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra:	1 vnt.
Apiksabanas	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
115123	101233	1101233	lizdinė plokštelė	N28		Receptinis	LT/1/24/5590/001	Netiekiama	-	-	No	-	-
115124	101234	1101234	lizdinė plokštelė	N56		Receptinis	LT/1/24/5590/002	Netiekiama	-	-	No	-	-
115125	101235	1101235	lizdinė plokštelė	N60		Receptinis	LT/1/24/5590/003	Netiekiama	-	-	No	-	-
115126	101236	1101236	lizdinė plokštelė	N168		Receptinis	LT/1/24/5590/004	Netiekiama	-	-	No	-	-
115127	101237	1101237	buteliukas	N200		Receptinis	LT/1/24/5590/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-09-25	Registruotas