Akeega

Medicinal product

(Invented) name

Akeega

Active substance (s)

Niraparibas/Abiraterono acetatas

Strength

50 mg/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)

L01XK52, niraparib and abiraterone

Marketing authorisation holder

Janssen Pharmaceutica N.V., Belgija

Date of authorisation

2023-04-19

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10b

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Film-coated tablet	1 vnt.
Niraparibas	50 mg
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
110907	97018	1097018	lizdinė plokštelė	N56		Receptinis	EU/1/23/1722/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-04-19	Registruotas