Zoledronic acid Fresenius Kabi

Medicinal product

(Invented) name

Zoledronic acid Fresenius Kabi

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

Fresenius Kabi Polska Sp.z.o.o., Lenkija

Date of authorisation

2012-10-19

Date of renewal

2018-07-30

Documents

3109 Zoledronic acid Fresenius Kabi RPP 2024 08 26.docx

3109 Pakuotės lapelis 2024 08 26.docx

Zoledronic acid Fresenius Kabi paciento kortelė.PDF

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

PT/H/0653/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Viename 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
46480	60288	1060288	flakonas	5 ml N1		Receptinis	LT/1/12/3109/001	Tiekiama	-	-	No	-	-	Download
54102	68090	1068090	flakonas	5 ml N4		Receptinis	LT/1/12/3109/002	Netiekiama	-	-	No	-	-
54103	68091	1068091	flakonas	5 ml N10		Receptinis	LT/1/12/3109/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-07-30	Perregistruotas
2012-10-19	Registruotas