Zoledronic Acid Accord

Medicinal product

(Invented) name

Zoledronic Acid Accord

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

Accord Healthcare S.L.U., Ispanija

Date of authorisation

2014-01-16

Date of renewal

Documents

Paciento primenamoji kortelė.docx

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
58462	72626	1072626	flakonas	5 ml N1		Receptinis	EU/1/13/834/001	Netiekiama	2025-01-02	2025-11-28	No	-	-
58463	72627	1072627	flakonas	5 ml N4		Receptinis	EU/1/13/834/002	Netiekiama	-	-	No	-	-
58464	72628	1072628	flakonas	5 ml N10		Receptinis	EU/1/13/834/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-01-16	Registruotas