Veoza

Medicinal product

(Invented) name

Veoza

Active substance (s)

Fezolinetantas

Strength

45 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)

G02CX06, fezolinetant

Marketing authorisation holder

Astellas Pharma Europe B.V., Nyderlandai

Date of authorisation

2023-12-07

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.
Fezolinetantas	45 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
112449	98569	1098569	dalomoji lizdinė plokštelė	N28×1		Receptinis	EU/1/23/1771/001	Netiekiama	-	-	No	-	-
112450	98570	1098570	dalomoji lizdinė plokštelė	N30×1		Receptinis	EU/1/23/1771/002	Netiekiama	-	-	No	-	-
112451	98571	1098571	dalomoji lizdinė plokštelė	N100×1		Receptinis	EU/1/23/1771/003	Netiekiama	-	-	No	-	-
113411	99529	1099529	dalomoji lizdinė plokštelė	N10×1		Receptinis	EU/1/23/1771/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-12-07	Registruotas