Nilotinib Olpha

Medicinal product

(Invented) name

Nilotinib Olpha

Active substance (s)

Nilotinibas

Strength

200 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

Olpha AS, Latvija

Date of authorisation

2026-05-20

Date of renewal

Documents

6035-6036_Nilotinib Olpha.docx

6035-36_pakuotes lapelis_2026-05-20.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DE/H/8198/003/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kapsulėje yra	1 vnt.
Nilotinibas	200 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
120961	107069	1107069	lizdinė plokštelė	N28		Receptinis	LT/1/26/6036/001	Netiekiama	-	-	No	-	-
120962	107070	1107070	lizdinė plokštelė	N112 (4×28)		Receptinis	LT/1/26/6036/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2026-05-20	Registruotas