Osagrand

Medicinal product

(Invented) name

Osagrand

Active substance (s)

Ibandrono rūgštis

Strength

3 mg

Pharmaceutical form

injekcinis tirpalas

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

Zentiva k.s., Čekija

Date of authorisation

2011-11-22

Date of renewal

2017-02-27

Documents

2692 Pakuotės lapelis 2024 08 22.docx

2692 Osagrand PCS PL 2024 08 22.docx

Osagrand paciento kortele.pdf

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

CZ/H/0255/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kiekvienoje 3 ml tirpalo ampulėje yra	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
40388	54125	1054125	ampulė	3 ml N1		Receptinis	LT/1/11/2692/001	Tiekiama	-	-	No	-	-	Download
50022	63897	1063897	ampulė	3 ml N4		Receptinis	LT/1/11/2692/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-02-27	Perregistruotas
2011-11-22	Registruotas