Afinitor

Medicinal product

(Invented) name

Afinitor

Active substance (s)

Everolimuzas

Strength

10 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	10 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
37112	50731	1050731	lizdinė plokštelė	N30		Receptinis	EU/1/09/538/004	Netiekiama	-	-	No	-	-
37114	50733	1050733	lizdinė plokštelė	N90		Receptinis	EU/1/09/538/006	Netiekiama	-	-	No	-	-
56196	70280	1070280	lizdinė plokštelė	N10		Receptinis	EU/1/09/538/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2009-08-03	Registruotas