Enzalutamide Viatris

Medicinal product

(Invented) name

Enzalutamide Viatris

Active substance (s)

Enzalutamidas

Strength

80 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	80 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
114747	100854	1100854	lizdinė plokštelė	N56		Receptinis	EU/1/24/1842/004	Netiekiama	-	-	No	-	-
114748	100855	1100855	lizdinė plokštelė	N56 (kalendorinė)	kalendorinė pakuotė	Receptinis	EU/1/24/1842/005	Netiekiama	-	-	No	-	-
114749	100856	1100856	dalomoji lizdinė plokštelė	N56×1		Receptinis	EU/1/24/1842/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-08-22	Registruotas