Zoledronic acid Teva Generics

Medicinal product

(Invented) name

Zoledronic acid Teva Generics

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 Generics B.V., Nyderlandai

Date of authorisation

2014-03-27

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
58875	73092	1073092	buteliukas	100 ml N1		Receptinis	EU/1/14/912/001	Netiekiama	-	-	No	-	-
58876	73093	1073093	buteliukas	100 ml N5 (grupinė)		Receptinis	EU/1/14/912/002	Netiekiama	-	-	No	-	-
58877	73094	1073094	buteliukas	100 ml N10 (grupinė)		Receptinis	EU/1/14/912/003	Netiekiama	-	-	No	-	-
58878	73095	1073095	maišelis	100 ml N5 (grupinė)		Receptinis	EU/1/14/912/004	Netiekiama	-	-	No	-	-
58879	73096	1073096	maišelis	100 ml N10 (grupinė)		Receptinis	EU/1/14/912/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
	Išregistruotas
2014-03-27	Registruotas