Zoledronic acid Teva

Medicinal product

(Invented) name

Zoledronic acid Teva

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

Teva B.V., Nyderlandai

Date of authorisation

2012-08-16

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

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
53714	67697	1067697	flakonas	5 ml N1 (plastiko)		Receptinis	EU/1/12/771/001	Netiekiama	-	-	No	-	-
53715	67698	1067698	flakonas	5 ml N4 (plastiko)		Receptinis	EU/1/12/771/002	Netiekiama	-	-	No	-	-
53716	67699	1067699	flakonas	5 ml N10 (plastiko)		Receptinis	EU/1/12/771/003	Netiekiama	-	-	No	-	-
53717	67700	1067700	flakonas	5 ml N1 (stiklo)		Receptinis	EU/1/12/771/004	Netiekiama	-	-	No	-	-
53718	67701	1067701	flakonas	5 ml N4 (stiklo)		Receptinis	EU/1/12/771/005	Netiekiama	-	-	No	-	-
53719	67702	1067702	flakonas	5 ml N10 (stiklo)		Receptinis	EU/1/12/771/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2012-08-16	Registruotas