OSSICA

Medicinal product

(Invented) name

OSSICA

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

Gedeon Richter Plc, Vengrija

Date of authorisation

2011-12-16

Date of renewal

2017-06-13

Documents

2734_05-06 pakuotes lapelis_170613.docx

2734_5-6 OSSICA_3ml_perr0613.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

HU/H/0211/005/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Viename užpildytame švirkšte (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
40036	53763	1053763	užpildytas švirkštas	3 ml ir injekcinė adata N1	PAĮ	Receptinis	LT/1/11/2734/005	Netiekiama	-	-	No	-	-	Download
50624	64510	1064510	užpildytas švirkštas	3 ml ir injekcinė adata N4		Receptinis	LT/1/11/2734/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-01-29	Išregistruotas
2017-06-13	Perregistruotas
2011-12-16	Registruotas