Xtandi

Medicinal product

(Invented) name

Xtandi

Active substance (s)

Enzalutamidas

Strength

80 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)

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

Film-coated tablet	1 vnt.
Enzalutamidas	80 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
98158	84256	1084256	lizdinė plokštelė	N56		Receptinis	EU/1/13/846/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2013-06-21	Registruotas