Enzalutamide Viatris

Medicinal product

(Invented) name

Enzalutamide Viatris

Active substance (s)

Enzalutamidas

Strength

40 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 mg
Enzalutamidas	40 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
114744	100851	1100851	lizdinė plokštelė	N112		Receptinis	EU/1/24/1842/001	Netiekiama	-	-	No	-	-
114745	100852	1100852	lizdinė plokštelė	N112 (kalendorinė)	kalendorinė pakuotė	Receptinis	EU/1/24/1842/002	Netiekiama	-	-	No	-	-
114746	100853	1100853	dalomoji lizdinė plokštelė	N112×1		Receptinis	EU/1/24/1842/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-08-22	Registruotas