Axitinib Accord

Medicinal product

(Invented) name

Axitinib Accord

Active substance (s)

Aksitinibas

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)

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	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
115148	101258	1101258	lizdinė plokštelė	N28		Receptinis	EU/1/24/1847/011	Netiekiama	-	-	No	-	-
115149	101259	1101259	dalomoji lizdinė plokštelė	N28×1		Receptinis	EU/1/24/1847/012	Netiekiama	-	-	No	-	-
115151	101260	1101260	lizdinė plokštelė	N56		Receptinis	EU/1/24/1847/013	Netiekiama	-	-	No	-	-
115152	101261	1101261	dalomoji lizdinė plokštelė	N56×1		Receptinis	EU/1/24/1847/014	Netiekiama	-	2025-12-31	Yes	2025-07-02	2025-12-31
115153	101262	1101262	buteliukas	N60		Receptinis	EU/1/24/1847/015	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-09-19	Registruotas