Enzalutamide Hexal

Medicinal product

(Invented) name

Enzalutamide Hexal

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

Sandoz d.d., Slovėnija

Date of authorisation

2025-12-04

Date of renewal

Documents

5918_pakuotes lapelis_2025-12-04.docx

5918_Enzalutamide Hexal.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

NL/H/5851/003/DC

Marketing authorisation procedure

Decentralizuota procedūra

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
119336	105439	1105439	lizdinė plokštelė	N28		Receptinis	LT/1/25/5918/001	Netiekiama	-	-	No	-	-
119337	105440	1105440	lizdinė plokštelė	N56		Receptinis	LT/1/25/5918/002	Netiekiama	-	-	No	-	-
119338	105441	1105441	dalomoji lizdinė plokštelė	N28×1		Receptinis	LT/1/25/5918/003	Netiekiama	-	-	No	-	-
119339	105442	1105442	dalomoji lizdinė plokštelė	N56×1		Receptinis	LT/1/25/5918/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-12-04	Registruotas