Zytiga

Medicinal product

(Invented) name

Zytiga

Active substance (s)

Abirateronas

Strength

500 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)

L02BX03, Abiraterone

Marketing authorisation holder

Janssen-Cilag International N.V., Belgija

Date of authorisation

2011-09-05

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.
Abirateronas	500 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
67484	82037	1082037	lizdinė plokštelė	N56 (4x14)		Receptinis	EU/1/11/714/002	Netiekiama	-	-	No	-	-
67485	82038	1082038	lizdinė plokštelė	N60 (5x12)		Receptinis	EU/1/11/714/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2011-09-05	Registruotas