Zoledronic acid Hikma [Ribometa]

Medicinal product

(Invented) name

Zoledronic acid Hikma [Ribometa]

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 Edupharma, Lietuva

Date of authorisation

2019-12-31

Date of renewal

Documents

1164_Zoledronic_Acid_Hikma_PZ_2023-08-22_K.docx

1164_Zoledronic_Acid_Hikma_2023-08-22_PL_K.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Lygiagretus importas

Qualitative and quantitative composition

Viename 5 ml koncentrato flakone 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
103058	89159	1089159	flakonas	5 ml N1	ASPĮ	Receptinis	LT/L/19/1164/001	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2024-02-21	Išregistruotas
2019-12-31	Registruotas