Zometa

Medicinal product

(Invented) name

Zometa

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

Phoenix Labs Unlimited Company, Airija

Date of authorisation

2003-03-24

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

Concentrate for solution for infusion	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
28996	31507	1031507	flakonas	N1		Receptinis	EU/1/01/176/004	Netiekiama	-	-	No	-	-
28997	31508	1031508	flakonas	N4		Receptinis	EU/1/01/176/005	Netiekiama	-	-	No	-	-
28998	31509	1031509	flakonas	N10 (10x1) (grupinė)		Receptinis	EU/1/01/176/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2003-03-24	Registruotas