Enzalutamide Viatris

Medicinal product

(Invented) name

Enzalutamide Viatris

Active substance (s)

Enzalutamidas

Strength

160 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

Viatris Limited, Airija

Date of authorisation

2024-08-22

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Tabletėje yra:	1 vnt.
Enzalutamidas	160 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
119190	105294	1105294	lizdinė plokštelė	N28		Receptinis	EU/1/24/1842/007	Netiekiama	-	-	No	-	-
119191	105295	1105295	dalomoji lizdinė plokštelė	N28×1		Receptinis	EU/1/24/1842/008	Netiekiama	-	-	No	-	-
119192	105296	1105296	lizdinė plokštelė	N28 (kalendorinė)	kalendorinė pakuotė	Receptinis	EU/1/24/1842/009	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-08-22	Registruotas