Ibandronic acid Briz

Medicinal product

(Invented) name

Ibandronic acid Briz

Active substance (s)

Ibandrono rūgštis

Strength

3 mg/3 ml

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

SIA Briz, Latvija

Date of authorisation

2014-07-01

Date of renewal

2018-10-26

Documents

3588_1_2 Ibandronic acid Briz inj RPP 190228.docx

3588_1_2 Pakuotės lapelis 190228.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

LV/H/0113/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Vienoje ampulėje (3 ml tirpalo) 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
56635	70735	1070735	ampulė	3 ml N1		Receptinis	LT/1/14/3588/001	Netiekiama	-	-	No	-	-	Download
59623	73854	1073854	ampulė	3 ml N4		Receptinis	LT/1/14/3588/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-10-02	Išregistruotas
2018-10-26	Perregistruotas
2014-07-01	Registruotas