Enzalutamide Hexal

Medicinal product

(Invented) name

Enzalutamide Hexal

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

Sandoz d.d., Slovėnija

Date of authorisation

2024-07-24

Date of renewal

Documents

5505_5506 Enzalutamide Hexal PCS 2025 08 05.docx

5505_5506 Pakuotės lapelis 2024 11 13.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/5851/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

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
114282	100394	1100394	lizdinė plokštelė	N56		Receptinis	LT/1/24/5506/001	Netiekiama	-	2028-07-01	No	-	-
114283	100395	1100395	dalomoji lizdinė plokštelė	N56×1		Receptinis	LT/1/24/5506/002	Netiekiama	-	-	No	-	-
114284	100396	1100396	lizdinė plokštelė	N56 (4×14) (kartonins dėklas)		Receptinis	LT/1/24/5506/003	Netiekiama	-	-	No	-	-
114285	100397	1100397	buteliukas	N56		Receptinis	LT/1/24/5506/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-07-24	Registruotas