Zolacitor

Medicinal product

(Invented) name

Zolacitor

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

Norameda, UAB, Lietuva

Date of authorisation

2012-10-19

Date of renewal

Documents

3108_01-02 Zolacitor_DP.doc

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kiekviename 5 ml koncentrato flakone 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
45870	59674	1059674	flakonas	5 ml N1		Receptinis	LT/1/12/3108/001	Netiekiama	-	-	No	-	-
54101	68089	1068089	flakonas	5 ml N4		Receptinis	LT/1/12/3108/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-03-15	Išregistruotas
2012-10-19	Registruotas