Krufton

Medicinal product

(Invented) name

Krufton

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

Egis Pharmaceuticals PLC, Vengrija

Date of authorisation

2024-08-05

Date of renewal

Documents

5529_5531 Pakuotės lapelis 2024 09 18.docx

5529_5531 Krufton RPP 2024 09 18.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

HU/H/0889/003/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
114396	100507	1100507	lizdinė plokštelė	N112 (4×28)		Receptinis	LT/1/24/5531/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-08-05	Registruotas