Zendractin

Medicinal product

(Invented) name

Zendractin

Active substance (s)

Zoledrono rūgštis

Strength

4 mg/100 ml

Pharmaceutical form

infuzinis tirpalas

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

PharmaSwiss Česká republika s.r.o., Čekija

Date of authorisation

2013-10-09

Date of renewal

Documents

3383_1_4 Zendractin inf RPP 160115.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/2767/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Viename flakone yra	100 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
53105	67047	1067047	flakonas	100 ml N1		Receptinis	LT/1/13/3383/001	Netiekiama	-	-	No	-	-	Download
57477	71593	1071593	flakonas	100 ml N4		Receptinis	LT/1/13/3383/002	Netiekiama	-	-	No	-	-
57478	71594	1071594	flakonas	100 ml N5		Receptinis	LT/1/13/3383/003	Netiekiama	-	-	No	-	-
57479	71595	1071595	flakonas	100 ml N10		Receptinis	LT/1/13/3383/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-08-01	Išregistruotas
2013-10-09	Registruotas