Zoledronic acid medac

Medicinal product

(Invented) name

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)

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

Išregistruotas

Controlled?

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	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To
53343	67324	1067324	flakonas	5 ml N1	Receptinis	EU/1/12/779/001	Netiekiama	-	-	No	-	-
53344	67325	1067325	flakonas	5 ml N4 (4x1) (grupinė)	Receptinis	EU/1/12/779/002	Netiekiama	-	-	No	-	-
53345	67326	1067326	flakonas	5 ml N10 (10x1) (grupinė)	Receptinis	EU/1/12/779/003	Netiekiama	-	-	No	-	-
66328	80853	1080853	flakonas	5 ml N4	Receptinis	EU/1/12/779/007	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
	Išregistruotas
2012-08-03	Registruotas