Inlyta

Medicinal product

(Invented) name

Inlyta

Active substance (s)

Aksitinibas

Strength

5 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)

L01EK01, axitinib

Marketing authorisation holder

Pfizer Europe MA EEIG, Belgija

Date of authorisation

2012-09-03

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.
Aksitinibas	5 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
53731	67714	1067714	lizdinė plokštelė	N28		Receptinis	EU/1/12/777/004	Netiekiama	-	-	No	-	-
53732	67715	1067715	lizdinė plokštelė	N56		Receptinis	EU/1/12/777/005	Tiekiama	-	-	No	-	-
53733	67716	1067716	buteliukas	N60		Receptinis	EU/1/12/777/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2012-09-03	Registruotas