APIXABAN GEDEON RICHTER

Medicinal product

(Invented) name

APIXABAN GEDEON RICHTER

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

Gedeon Richter Plc, Vengrija

Date of authorisation

2024-09-17

Date of renewal

Documents

Apixaban Gedeon Richter mokomoji medziaga sveikatos prieziuros specialistams.pdf

5569 APIXABAN GEDEON RICHTER 5mg PCS PL 2025 04 16.docx

5569 Pakuotės lapelis 2025 04 16.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

HU/H/0871/002/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
115091	101201	1101201	lizdinė plokštelė	N28		Receptinis	LT/1/24/5569/001	Netiekiama	-	2025-09-30	No	-	-
115092	101202	1101202	lizdinė plokštelė	N56		Receptinis	LT/1/24/5569/002	Netiekiama	-	2025-09-30	No	-	-
115093	101203	1101203	lizdinė plokštelė	N60		Receptinis	LT/1/24/5569/003	Netiekiama	-	2025-09-30	No	-	-
115094	101204	1101204	lizdinė plokštelė	N168		Receptinis	LT/1/24/5569/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-09-17	Registruotas