Ferinject

Medicinal product

(Invented) name

Ferinject

Active substance (s)

Geležies karboksimaltozė

Strength

50 mg/ml

Pharmaceutical form

injekcinis ar infuzinis tirpalas

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

B03AC, Iron, parenteral preparations

Marketing authorisation holder

Vifor France, Prancūzija

Date of authorisation

2008-05-12

Date of renewal

2012-12-05

Documents

1133_1_7 Pakuotės lapelis 181228.docx

1133_1_7 Ferinject_inj_inf PCS PL 181228.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

SE/H/1816/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Geležies karboksimaltozė	50 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
19262	22620	1022620	flakonas	2 ml N5		Receptinis	LT/1/08/1133/001	Netiekiama	-	-	No	-	-
19263	22621	1022621	flakonas	10 ml N5		Receptinis	LT/1/08/1133/002	Netiekiama	-	-	No	-	-
32917	35297	1035297	flakonas	2 ml N1		Receptinis	LT/1/08/1133/003	Netiekiama	-	-	No	-	-
32918	35298	1035298	flakonas	10 ml N1		Receptinis	LT/1/08/1133/004	Netiekiama	-	-	No	-	-
49009	62875	1062875	flakonas	2 ml N2		Receptinis	LT/1/08/1133/005	Netiekiama	-	-	No	-	-
49010	62876	1062876	flakonas	10 ml N2		Receptinis	LT/1/08/1133/006	Netiekiama	-	-	No	-	-
57943	72065	1072065	flakonas	20 ml N1		Receptinis	LT/1/08/1133/007	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-07-02	Išregistruotas
2012-12-05	Perregistruotas
2008-05-12	Registruotas