Zerbaxa

Medicinal product

(Invented) name

Zerbaxa

Active substance (s)

Ceftolozanas/Tazobaktamas

Strength

1 g/0,5 g

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)

J01DI54, Ceftolozane and beta-lactamase inhibitor

Marketing authorisation holder

Merck Sharp & Dohme B.V., Nyderlandai

Date of authorisation

2015-09-18

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

Powder for concentrate for solution for infusion	1 vnt.
Ceftolozanas	1 g
Tazobaktamas	0,5 g

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
63727	78169	1078169	flakonas	N10		Receptinis	EU/1/15/1032/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-09-18	Registruotas