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

Sandoz Pharmaceuticals d.d., Slovėnija

Date of authorisation

2005-04-15

Date of renewal

Documents

Aclasta paciento kortelė.pdf

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Solution for infusion	100 ml
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
23710	5667	1005667	buteliukas	100 ml N1		Receptinis	EU/1/05/308/001	Netiekiama	2025-08-11	2025-09-16	No	-	-
23711	26398	1026398	buteliukas	100 ml N5x1		Receptinis	EU/1/05/308/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2005-04-15	Registruotas