OSSICA

Medicinal product

(Invented) name

OSSICA

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

Gedeon Richter Plc, Vengrija

Date of authorisation

2010-03-05

Date of renewal

2015-05-26

Documents

1902_3_4 OSSICA 150mg tab PZ 171218.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

HU/H/0211/002/DC

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
31236	5608	1005608	lizdinė plokštelė	N1		Receptinis	LT/1/10/1902/003	Netiekiama	-	-	No	-	-	Download
40059	53786	1053786	lizdinė plokštelė	N3		Receptinis	LT/1/10/1902/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-07-02	Išregistruotas
2015-05-26	Perregistruotas
2010-03-05	Registruotas