Zometa

Medicinal product

(Invented) name

Zometa

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

Phoenix Labs Unlimited Company, Airija

Date of authorisation

2011-08-24

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

Solution for infusion	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
49263	63131	1063131	buteliukas	100 ml N1		Receptinis	EU/1/01/176/007	Netiekiama	-	-	No	-	-
49264	63132	1063132	buteliukas	100 ml N4 (4x1, grupinė)		Receptinis	EU/1/01/176/008	Netiekiama	-	-	No	-	-
49265	63133	1063133	buteliukas	100 ml N5 (5x1, grupinė)		Receptinis	EU/1/01/176/009	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2011-08-24	Registruotas