NUBEQA

Medicinal product

(Invented) name

NUBEQA

Active substance (s)

Darolutamidas

Strength

300 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)

L02BB06, darolutamide

Marketing authorisation holder

Bayer AG, Vokietija

Date of authorisation

2020-03-27

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Film-coated tablet	1 vnt.
Darolutamidas	300 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
103707	89809	1089809	lizdinė plokštelė	N112		Receptinis	EU/1/20/1432/001	Tiekiama	2025-08-19	-	No	-	-
104226	90330	1090330	lizdinė plokštelė	N96		Receptinis	EU/1/20/1432/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-03-27	Registruotas