Zometa

Medicinal product

(Invented) name

Zometa

Active substance (s)

Zoledrono rūgštis

Strength

4 mg

Pharmaceutical form

milteliai ir tirpiklis 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

2001-03-20

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

powder and solvent for solution for infusion	1 vnt.
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
6157	11297	1011297	flakonas	milteliai ir tirpiklio ampulė (5 ml) N1		Receptinis	EU/1/01/176/001	Netiekiama	-	-	No	-	-
28994	31505	1031505	flakonas	milteliai ir tirpiklio ampulė (5 ml) N4		Receptinis	EU/1/01/176/002	Netiekiama	-	-	No	-	-
28995	31506	1031506	flakonas	milteliai ir tirpiklio ampulė (5 ml) N10 (10x1+1) (grupinė)		Receptinis	EU/1/01/176/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2001-03-20	Registruotas