Zercepac

Medicinal product

(Invented) name

Zercepac

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

Accord Healthcare S.L.U., Ispanija

Date of authorisation

2020-07-27

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

Powder for concentrate for solution for infusion	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
106730	92832	1092832	flakonas	N1		Receptinis	EU/1/20/1456/003	Tiekiama	2025-01-27	-	Yes	2025-01-01	2025-06-30

Stadijos

Data	Stadija
2020-07-27	Registruotas