Iclusig

Medicinal product

(Invented) name

Iclusig

Active substance (s)

Ponatinibas

Strength

45 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	45 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
56657	70760	1070760	buteliukas	N30		Receptinis	EU/1/13/839/003	Netiekiama	-	-	No	-	-
56658	70761	1070761	buteliukas	N90		Receptinis	EU/1/13/839/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2013-07-01	Registruotas