Aclasta

Medicinal product

(Invented) name

Aclasta

Active substance (s)

Zoledrono rūgštis

Strength

5 mg

Pharmaceutical form

infuzinis tirpalas

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

Abacus Medicine A/S, Danija

Date of authorisation

2025-03-26

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

CR-Lygiagretus platinimas

Qualitative and quantitative composition

Solution for infusion	1 vnt.
Zoledrono rūgštis	5 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
117956	104061	1104061	buteliukas	100 ml N1		Receptinis	EU/1/05/308/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-03-26	Registruotas