Iclusig

Medicinal product

(Invented) name

Iclusig

Active substance (s)

Ponatinibas

Strength

15 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01EA05, ponatinib

Marketing authorisation holder

Incyte Biosciences Distribution B.V., Nyderlandai

Date of authorisation

2013-07-01

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

Film-coated tablet	1 vnt.
Ponatinibas	15 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
56655	70758	1070758	buteliukas	N60		Receptinis	EU/1/13/839/001	Netiekiama	-	-	No	-	-
56656	70759	1070759	buteliukas	N180		Receptinis	EU/1/13/839/002	Netiekiama	-	-	No	-	-
64676	79163	1079163	buteliukas	N30		Receptinis	EU/1/13/839/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2013-07-01	Registruotas