Ziihera

Medicinal product

(Invented) name

Ziihera

Active substance (s)

Zanidatamabas

Strength

300 mg

Pharmaceutical form

milteliai infuzinio tirpalo koncentratui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01FD07, zanidatamab

Marketing authorisation holder

Jazz Pharmaceuticals Ireland Ltd., Airija

Date of authorisation

2025-06-27

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

Flakone yra	1 vnt.
Zanidatamabas	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
117910	104015	1104015	flakonas	N1		Receptinis	EU/1/25/1931/001	Netiekiama	-	-	No	-	-
117911	104016	1104016	flakonas	N2		Receptinis	EU/1/25/1931/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-06-27	Registruotas