Enzalutamide STADA

Medicinal product

(Invented) name

Enzalutamide STADA

Active substance (s)

Enzalutamidas

Strength

40 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 Pakuotės lapelis 2024 09 24.docx

5507_5508 Enzalutamide STADA PCS 2025 07 17.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/5871/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje 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
114286	100398	1100398	lizdinė plokštelė	N112		Receptinis	LT/1/24/5507/001	Netiekiama	-	-	No	-	-
114287	100399	1100399	dalomoji lizdinė plokštelė	N112×1		Receptinis	LT/1/24/5507/002	Netiekiama	-	-	No	-	-
114288	100400	1100400	buteliukas	N112		Receptinis	LT/1/24/5507/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-07-24	Registruotas