Zoledronic acid Norameda

Medicinal product

(Invented) name

Zoledronic acid Norameda

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

UAB Norameda, Lietuva

Date of authorisation

2016-11-10

Date of renewal

2022-01-17

Documents

3997_pakuotes lapelis_2022-01-17.docx

Zoledronic Acid Norameda paciento kortele.pdf

3997_Zoledronic acid Norameda_perr2022-01-17t.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

EE/H/0379/001/MR

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

5 ml koncentrato yra	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
67060	81602	1081602	flakonas	5 ml N1		Receptinis	LT/1/16/3997/001	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2025-09-29	Išregistruotas
2022-01-17	Perregistruotas
2016-11-10	Registruotas