Erleada

Medicinal product

(Invented) name

Erleada

Active substance (s)

Apalutamidas

Strength

240 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

Tabletėje yra:	1 vnt.
Apalutamidas	240 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
111551	97664	1097664	lizdinė plokštelė	N28		Receptinis	EU/1/18/1342/004	Netiekiama	-	-	No	-	-
111552	97665	1097665	lizdinė plokštelė	N30		Receptinis	EU/1/18/1342/005	Tiekiama	-	-	No	-	-
111553	97666	1097666	buteliukas	N30		Receptinis	EU/1/18/1342/006	Netiekiama	-	-	No	-	-
117932	104037	1104037	lizdinė plokštelė	N84		Receptinis	EU/1/18/1342/007	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-01-14	Registruotas