Finlee

Medicinal product

(Invented) name

Finlee

Active substance (s)

Dabrafenibas

Strength

10 mg

Pharmaceutical form

disperguojamosios tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01EC02, dabrafenib

Marketing authorisation holder

Novartis Europharm Ltd., Airija

Date of authorisation

2023-11-15

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Tabletėje yra:	1 vnt.
Dabrafenibas	10 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
112025	98140	1098140	buteliukas	N210 (210×1) ir 2 dozavimo taurelės		Receptinis	EU/1/23/1767/001	Netiekiama	-	-	No	-	-
112026	98141	1098141	buteliukas	N420 (210×2) ir 2 dozavimo taurelės		Receptinis	EU/1/23/1767/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-11-15	Registruotas