BAXOGAR

Medicinal product

(Invented) name

BAXOGAR

Active substance (s)

Ibandrono rūgštis

Strength

150 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

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

2010-11-24

Date of renewal

2018-09-10

Documents

2233 BAXOGAR 150mg RPP 2022 01 01.docx

2233 Pakuotės lapelis 2022 01 01.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DK/H/3065/001

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Ibandrono rūgštis	150 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
34068	36425	1036425	lizdinė plokštelė	N1		Receptinis	LT/1/10/2233/001	Netiekiama	-	-	No	-	-
43830	57615	1057615	lizdinė plokštelė	N3		Receptinis	LT/1/10/2233/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-03-31	Išregistruotas
2018-09-10	Perregistruotas
2010-11-24	Registruotas