Herzuma

Medicinal product

(Invented) name

Herzuma

Active substance (s)

Trastuzumabas

Strength

420 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)

L01FD01, trastuzumab

Marketing authorisation holder

Celltrion Healthcare Hungary Kft., Vengrija

Date of authorisation

2018-02-09

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(4)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Flakone yra	1 vnt.
Trastuzumabas	420 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
100426	86535	1086535	flakonas	N1		Receptinis	EU/1/17/1257/002	Netiekiama	-	-	No	-	-
117206	103306	1103306	flakonas	N2		Receptinis	EU/1/17/1257/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-02-09	Registruotas