Enzalutamide Sandoz d.d.

Medicinal product

(Invented) name

Enzalutamide Sandoz d.d.

Active substance (s)

Enzalutamidas

Strength

40 mg

Pharmaceutical form

minkštosios kapsulės

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

2025-04-24

Date of renewal

Documents

5766_Enzalutamide Sandoz dd.docx

5766_pakuotes lapelis_2025-04-24.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

FI/H/1247/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kapsulėje yra	1 vnt.
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
117258	103358	1103358	lizdinė plokštelė	N28		Receptinis	LT/1/25/5766/001	Netiekiama	-	-	No	-	-
117259	103359	1103359	lizdinė plokštelė	N112		Receptinis	LT/1/25/5766/002	Netiekiama	-	-	No	-	-
117260	103360	1103360	lizdinė plokštelė	N120		Receptinis	LT/1/25/5766/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-04-24	Registruotas