Abiraterone Accord

Medicinal product

(Invented) name

Abiraterone Accord

Active substance (s)

Abirateronas

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

Accord Healthcare S.L.U., Ispanija

Date of authorisation

2021-04-26

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Film-coated tablet	1 vnt.
Abirateronas	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
106484	92585	1092585	dalomoji lizdinė plokštelė	N56x1		Receptinis	EU/1/20/1512/002	Netiekiama	-	-	No	-	-
106485	92586	1092586	dalomoji lizdinė plokštelė	N60x1		Receptinis	EU/1/20/1512/003	Tiekiama	-	-	No	-	-
111706	97820	1097820	dalomoji lizdinė plokštelė	N112×1		Receptinis	EU/1/20/1512/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-04-26	Registruotas