Zurzuvae

Medicinal product

(Invented) name

Zurzuvae

Active substance (s)

Zuranolonas

Strength

25 mg

Pharmaceutical form

kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N06AX31, zuranolone

Marketing authorisation holder

Biogen Netherlands B.V., Nyderlandai

Date of authorisation

2025-09-17

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

Kapsulėje yra:	1 vnt.
Zuranolonas	25 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
118795	104901	1104901	buteliukas	N14		Receptinis	EU/1/25/1977/004	Netiekiama	-	-	No	-	-
118796	104902	1104902	buteliukas	N28		Receptinis	EU/1/25/1977/005	Netiekiama	-	-	No	-	-
118799	104905	1104905	lizdinė plokštelė	N28		Receptinis	EU/1/25/1977/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-09-17	Registruotas