Tatica

Medicinal product

(Invented) name

Tatica

Active substance (s)

Abiraterono acetatas

Strength

250 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 Pakuotės lapelis 2025 09 22.docx

4777_4778 Tatica_perr2025-09-22, PCS PZ rastas 21256 .docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/5263/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra:	1 vnt.
Abiraterono acetatas	250 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
106818	92921	1092921	lizdinė plokštelė	N112 (OPA/Al/PVC/Al)		Receptinis	LT/1/21/4777/001	Netiekiama	-	-	No	-	-
106819	92922	1092922	lizdinė plokštelė	N120 (OPA/Al/PVC/Al)		Receptinis	LT/1/21/4777/002	Netiekiama	-	-	No	-	-
119112	105217	1105217	lizdinė plokštelė	N112 (PVC/PE/PVDC/Al)		Receptinis	LT/1/21/4777/003	Netiekiama	-	-	No	-	-
119113	105218	1105218	lizdinė plokštelė	N120 (PVC/PE/PVDC/Al)		Receptinis	LT/1/21/4777/004	Netiekiama	-	-	No	-	-

Stadijos

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