Abiraterone Krka

Medicinal product

(Invented) name

Abiraterone Krka

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

KRKA, d.d., Novo mesto, Slovėnija

Date of authorisation

2021-06-24

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
106797	92900	1092900	lizdinė plokštelė	N56		Receptinis	EU/1/21/1553/001	Netiekiama	-	-	No	-	-
106798	92901	1092901	lizdinė plokštelė	N60		Receptinis	EU/1/21/1553/002	Tiekiama	-	-	No	-	-
106799	92902	1092902	lizdinė plokštelė	N56 (kalendorinė)		Receptinis	EU/1/21/1553/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-06-24	Registruotas