Zoledronic acid Teva Pharma

Medicinal product

(Invented) name

Zoledronic acid Teva Pharma

Active substance (s)

Zoledrono rūgštis

Strength

5 mg

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

Teva B.V., Nyderlandai

Date of authorisation

2012-08-16

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Solution for infusion	100 ml
Zoledrono rūgštis	5 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
53723	67706	1067706	buteliukas	100 ml N5 (5x1)		Receptinis	EU/1/12/772/001	Netiekiama	-	-	No	-	-
53724	67707	1067707	buteliukas	100 ml N10 (10x1)		Receptinis	EU/1/12/772/002	Netiekiama	-	-	No	-	-
53725	67708	1067708	maišelis	100 ml N5 (5x1)		Receptinis	EU/1/12/772/003	Netiekiama	-	-	No	-	-
53726	67709	1067709	maišelis	100 ml N10 (10x1)		Receptinis	EU/1/12/772/004	Netiekiama	-	-	No	-	-
57718	71837	1071837	buteliukas	100 ml N1		Receptinis	EU/1/12/772/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-01-22	Išregistruotas
2012-08-16	Registruotas