Nilotinib Accord

Medicinal product

(Invented) name

Nilotinib Accord

Active substance (s)

Nilotinibas

Strength

50 mg

Pharmaceutical form

kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01EA03, nilotinib

Marketing authorisation holder

Accord Healthcare S.L.U., Ispanija

Date of authorisation

2024-08-22

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

Kapsulėje yra:	1 vnt.
Nilotinibas	50 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
114716	100823	1100823	lizdinė plokštelė	N40		Receptinis	EU/1/24/1845/001	Netiekiama	-	-	No	-	-
114717	100824	1100824	dalomoji lizdinė plokštelė	N40×1		Receptinis	EU/1/24/1845/002	Netiekiama	-	-	No	-	-
114718	100825	1100825	lizdinė plokštelė	N120 (3×40)		Receptinis	EU/1/24/1845/003	Netiekiama	-	-	No	-	-
114719	100826	1100826	dalomoji lizdinė plokštelė	N120 (3×(N40×1))		Receptinis	EU/1/24/1845/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-08-22	Registruotas