Erleada

Medicinal product

(Invented) name

Erleada

Active substance (s)

Apalutamidas

Strength

60 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)

L02BB05, apalutamide

Marketing authorisation holder

Janssen-Cilag International N.V., Belgija

Date of authorisation

2019-01-14

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.
Apalutamidas	60 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
100815	86926	1086926	lizdinė plokštelė	N112 (28x4)		Receptinis	EU/1/18/1342/001	Netiekiama	-	-	No	-	-
100816	86927	1086927	lizdinė plokštelė	N120 (24x5)		Receptinis	EU/1/18/1342/002	Tiekiama	-	-	No	-	-
100814	86925	1086925	buteliukas	N120		Receptinis	EU/1/18/1342/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-01-14	Registruotas