Xtandi

Medicinal product

(Invented) name

Xtandi

Active substance (s)

Enzalutamidas

Strength

40 mg

Pharmaceutical form

minkštosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L02BB04, Enzalutamide

Marketing authorisation holder

Astellas Pharma Europe B.V., Nyderlandai

Date of authorisation

2013-06-21

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

Soft capsule	1 vnt.
Enzalutamidas	40 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
56684	70787	1070787	lizdinė plokštelė	N4x28		Receptinis	EU/1/13/846/001	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2013-06-21	Registruotas