Axitinib Accord

Medicinal product

(Invented) name

Axitinib Accord

Active substance (s)

Aksitinibas

Strength

1 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)

L01EK01, axitinib

Marketing authorisation holder

Accord Healthcare S.L.U., Ispanija

Date of authorisation

2024-09-19

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Tabletėje yra:	1 vnt.
Aksitinibas	1 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
115138	101248	1101248	lizdinė plokštelė	N28		Receptinis	EU/1/24/1847/001	Netiekiama	-	-	No	-	-
115139	101249	1101249	dalomoji lizdinė plokštelė	N28×1		Receptinis	EU/1/24/1847/002	Netiekiama	-	-	No	-	-
115140	101250	1101250	lizdinė plokštelė	N56		Receptinis	EU/1/24/1847/003	Netiekiama	-	-	No	-	-
115141	101251	1101251	dalomoji lizdinė plokštelė	N56×1		Receptinis	EU/1/24/1847/004	Netiekiama	-	-	No	-	-
115142	101252	1101252	buteliukas	N180		Receptinis	EU/1/24/1847/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-09-19	Registruotas