Enzalutamide STADA

Medicinal product

(Invented) name

Enzalutamide STADA

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

STADA Arzneimittel AG, Vokietija

Date of authorisation

2024-07-24

Date of renewal

Documents

5507_5508 Enzalutamide STADA PCS 2025 07 17.docx

5507_5508 Pakuotės lapelis 2024 09 24.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/5871/002/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
114289	100401	1100401	lizdinė plokštelė	N56		Receptinis	LT/1/24/5508/001	Netiekiama	-	-	No	-	-
114290	100402	1100402	dalomoji lizdinė plokštelė	N56×1		Receptinis	LT/1/24/5508/002	Netiekiama	-	-	No	-	-
114291	100403	1100403	buteliukas	N56		Receptinis	LT/1/24/5508/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-07-24	Registruotas