Abiraterone G.L. Pharma

Medicinal product

(Invented) name

Abiraterone G.L. Pharma

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

G.L. Pharma GmbH, Austrija

Date of authorisation

2021-05-24

Date of renewal

2025-10-09

Documents

4792_Abiraterone GL_perr2025-10-09.docx

4792_pakuotes lapelis_2025-10-09.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/4965/002/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
106561	92662	1092662	lizdinė plokštelė	N56		Receptinis	LT/1/21/4752/001	Netiekiama	-	-	No	-	-
106562	92663	1092663	lizdinė plokštelė	N56x1		Receptinis	LT/1/21/4752/002	Netiekiama	-	-	No	-	-
106563	92664	1092664	lizdinė plokštelė	N60		Receptinis	LT/1/21/4752/003	Tiekiama	-	-	No	-	-
106564	92666	1092666	lizdinė plokštelė	N60x1		Receptinis	LT/1/21/4752/004	Netiekiama	-	-	No	-	-
106565	92667	1092667	buteliukas	N60		Receptinis	LT/1/21/4752/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-10-09	Perregistruotas
2021-05-24	Registruotas