Zoledronic acid Mylan

Medicinal product

(Invented) name

Zoledronic acid Mylan

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

Mylan Pharmaceuticals Limited, Airija

Date of authorisation

2012-08-23

Date of renewal

Documents

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
53366	67348	1067348	flakonas	N1		Receptinis	EU/1/12/786/001	Netiekiama	-	-	No	-	-
53367	67349	1067349	flakonas	N4		Receptinis	EU/1/12/786/002	Netiekiama	-	-	No	-	-
53368	67350	1067350	flakonas	N10		Receptinis	EU/1/12/786/003	Netiekiama	-	-	No	-	-
57717	71836	1071836	flakonas	N4 (4×1)		Receptinis	EU/1/12/786/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2012-08-23	Registruotas