Ibandronic acid Accord

Medicinal product

(Invented) name

Ibandronic acid Accord

Active substance (s)

Ibandrono rūgštis

Strength

3 mg

Pharmaceutical form

injekcinis tirpalas užpildytame švirkšte

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

M05BA06, Ibandronic acid

Marketing authorisation holder

Accord Healthcare S.L.U., Ispanija

Date of authorisation

2012-11-19

Date of renewal

Documents

Ibandronic acid_laiškas gydytojams_DHCP.pdf

Ibandronic acid Accord injekcinio tirpalo paciento kortele.pdf

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Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Solution for injectionin in pre-filled syringe	3 ml
Ibandrono rūgštis	3 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
62419	76826	1076826	užpildytas švirkštas	3 ml ir injekcinė adata N1		Receptinis	EU/1/12/798/005	Netiekiama	2025-10-02	2025-12-30	No	-	-
62420	76827	1076827	užpildytas švirkštas	3 ml ir injekcinė adata N4		Receptinis	EU/1/12/798/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2012-11-19	Registruotas