Abiraterone Zentiva

Medicinal product

(Invented) name

Abiraterone Zentiva

Active substance (s)

Abiraterono acetatas

Strength

500 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)

L02BX03, Abiraterone

Marketing authorisation holder

Zentiva k.s., Čekija

Date of authorisation

2021-11-24

Date of renewal

Documents

4854 Abiraterone Zentiva II PL 2025 08 01.docx

4854 Pakuotės lapelis 2025 08 01.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/5242/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra:	1 vnt.
Abiraterono acetatas	500 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
107595	93700	1093700	lizdinė plokštelė	N56		Receptinis	LT/1/21/4854/001	Netiekiama	-	-	No	-	-
107596	93701	1093701	lizdinė plokštelė	N60		Receptinis	LT/1/21/4854/002	Netiekiama	2024-11-28	2025-02-28	No	-	-
107597	93702	1093702	lizdinė plokštelė	N120		Receptinis	LT/1/21/4854/003	Netiekiama	-	-	No	-	-
114703	100810	1100810	lizdinė plokštelė	N112		Receptinis	LT/1/21/4854/004	Netiekiama	-	-	No	-	-
117186	103286	1103286	lizdinė plokštelė	N90		Receptinis	LT/1/21/4854/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-11-24	Registruotas