Afinitor

Medicinal product

(Invented) name

Afinitor

Active substance (s)

Everolimuzas

Strength

5 mg

Pharmaceutical form

tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

Yes

ATC code (s)

L01EG02, everolimus

Marketing authorisation holder

Novartis Europharm Ltd., Airija

Date of authorisation

2009-08-03

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

Tablet	1 vnt.
Everolimuzas	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
37109	50728	1050728	lizdinė plokštelė	N30		Receptinis	EU/1/09/538/001	Tiekiama	-	-	No	-	-
37111	50730	1050730	lizdinė plokštelė	N90		Receptinis	EU/1/09/538/003	Netiekiama	-	-	No	-	-
56195	70279	1070279	lizdinė plokštelė	N10		Receptinis	EU/1/09/538/007	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2009-08-03	Registruotas