Abiraterone Olpha [Abiraterone Olainfarm]

Medicinal product

(Invented) name

Abiraterone Olpha [Abiraterone Olainfarm]

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

Olpha AS, Latvija

Date of authorisation

2023-12-08

Date of renewal

Documents

5283_5284 Abiraterone Olpha RPP 2025 06 19.docx

5283_5284 Pakuotės lapelis 2025 06 19.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DK/H/3125/002/E/001

Marketing authorisation procedure

Kartotinė 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
112264	98379	1098379	lizdinė plokštelė	N56		Receptinis	LT/1/23/5284/001	Netiekiama	-	-	No	-	-
112265	98380	1098380	lizdinė plokštelė	N60		Receptinis	LT/1/23/5284/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-12-08	Registruotas