Zoledronic acid Zentiva

Medicinal product

(Invented) name

Zoledronic acid Zentiva

Active substance (s)

Zoledrono rūgštis

Strength

4 mg/5 ml

Pharmaceutical form

koncentratas infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

M05BA08, Zoledronic acid

Marketing authorisation holder

Zentiva k.s., Čekija

Date of authorisation

2012-08-02

Date of renewal

Documents

3030_2_5 Zoledronic Zentiva PCS PL 160620.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/2321/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Viename buteliuke yra	5 ml
Zoledrono rūgštis	4 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
45693	59494	1059494	buteliukas	5 ml N1		Receptinis	LT/1/12/3030/002	Netiekiama	-	-	No	-	-	Download
53194	67136	1067136	buteliukas	5 ml N4		Receptinis	LT/1/12/3030/003	Netiekiama	-	-	No	-	-
53195	67137	1067137	buteliukas	5 ml N5		Receptinis	LT/1/12/3030/004	Netiekiama	-	-	No	-	-
53196	67138	1067138	buteliukas	5 ml N10		Receptinis	LT/1/12/3030/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-02-03	Išregistruotas
2012-08-02	Registruotas