Tatica

Medicinal product

(Invented) name

Tatica

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

Egis Pharmaceuticals PLC, Vengrija

Date of authorisation

2021-07-05

Date of renewal

2025-09-22

Documents

4777-8_Tatica_perr2025-09-22.docx

4777-8_pakuotes lapelis_2025-09-22.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/5263/002/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
106820	92923	1092923	lizdinė plokštelė	N56		Receptinis	LT/1/21/4778/001	Netiekiama	-	-	No	-	-
106821	92924	1092924	lizdinė plokštelė	N60		Receptinis	LT/1/21/4778/002	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-09-22	Perregistruotas
2021-07-05	Registruotas