Nilotinib Olpha

Medicinal product

(Invented) name

Nilotinib Olpha

Active substance (s)

Nilotinibas

Strength

150 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

6035-36_pakuotes lapelis_2026-05-20.docx

6035-6036_Nilotinib Olpha.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DE/H/8198/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kapsulėje yra	1 vnt.
Nilotinibas	150 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
120959	107067	1107067	lizdinė plokštelė	N28		Receptinis	LT/1/26/6035/001	Netiekiama	-	-	No	-	-
120960	107068	1107068	lizdinė plokštelė	N112 (4×28)		Receptinis	LT/1/26/6035/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2026-05-20	Registruotas