Zoledronic acid Actavis

Medicinal product

(Invented) name

Zoledronic acid Actavis

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

Actavis Group PTC ehf., Islandija

Date of authorisation

2012-04-20

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

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
52255	66175	1066175	flakonas	N1		Receptinis	EU/1/12/759/001	Netiekiama	-	-	No	-	-
52256	66176	1066176	flakonas	N4		Receptinis	EU/1/12/759/002	Netiekiama	-	-	No	-	-
52257	66177	1066177	flakonas	N10		Receptinis	EU/1/12/759/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-03-01	Išregistruotas
2012-04-20	Registruotas