Zoledronic acid medac

Medicinal product

(Invented) name

Active substance (s)

Zoledrono rūgštis

Strength

4 mg/100 ml

Pharmaceutical form

infuzinis tirpalas

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

M05BA08, Zoledronic acid

Marketing authorisation holder

medac Gesellschaft für klinische Spezialpräparate mbH, Vokietija

Date of authorisation

2012-08-03

Date of renewal

Documents

Stage

Registruotas

Controlled?

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Concentrate for solution for infusion	100 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
53346	67327	1067327	buteliukas	100 ml N1		Receptinis	EU/1/12/779/004	Netiekiama	-	-	No	-	-
53347	67328	1067328	buteliukas	100 ml N4		Receptinis	EU/1/12/779/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2012-08-03	Registruotas