Inlyta

Medicinal product

(Invented) name

Inlyta

Active substance (s)

Aksitinibas

Strength

3 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	3 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
60952	75260	1075260	lizdinė plokštelė	N28		Receptinis	EU/1/12/777/007	Netiekiama	-	-	No	-	-
60953	75261	1075261	lizdinė plokštelė	N56		Receptinis	EU/1/12/777/008	Netiekiama	-	-	No	-	-
60954	75262	1075262	buteliukas	N60		Receptinis	EU/1/12/777/009	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2012-09-03	Registruotas