Monofer

Medicinal product

(Invented) name

Monofer

Active substance (s)

Geležis

Strength

100 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

Pharmacosmos A/S, Danija

Date of authorisation

2010-03-05

Date of renewal

2015-05-26

Documents

1898 Pakuotės lapelis 2025 03 28.docx

Mokomoji medziaga sveikatos prieziuros specialistams.pdf

Mokomoji medziaga pacientams.pdf

1898 Monofer PCS PL 2025 03 28.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

SE/H/0734/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Geležis	100 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
30517	32978	1032978	ampulė	1 ml N5		Receptinis	LT/1/10/1898/001	Tiekiama	-	-	No	-	-	Download
30869	33324	1033324	ampulė	1 ml N10		Receptinis	LT/1/10/1898/002	Netiekiama	-	-	No	-	-
30870	33325	1033325	ampulė	2 ml N5		Receptinis	LT/1/10/1898/003	Tiekiama	-	-	No	-	-
30871	33326	1033326	ampulė	2 ml N10		Receptinis	LT/1/10/1898/004	Netiekiama	-	-	No	-	-
30872	33327	1033327	ampulė	5 ml N2		Receptinis	LT/1/10/1898/005	Netiekiama	-	-	No	-	-
39880	53579	1053579	ampulė	5 ml N5		Receptinis	LT/1/10/1898/006	Netiekiama	-	-	No	-	-
39881	53580	1053580	ampulė	10 ml N2		Receptinis	LT/1/10/1898/007	Netiekiama	-	-	No	-	-
39882	53581	1053581	ampulė	10 ml N5		Receptinis	LT/1/10/1898/008	Netiekiama	-	-	No	-	-
39883	53582	1053582	flakonas	1 ml N5		Receptinis	LT/1/10/1898/009	Tiekiama	-	-	No	-	-
39884	53583	1053583	flakonas	1 ml N10		Receptinis	LT/1/10/1898/010	Netiekiama	-	-	No	-	-
39885	53584	1053584	flakonas	2 ml N5		Receptinis	LT/1/10/1898/011	Netiekiama	-	-	No	-	-
39886	53585	1053585	flakonas	2 ml N10		Receptinis	LT/1/10/1898/012	Netiekiama	-	-	No	-	-
39887	53586	1053586	flakonas	5 ml N2		Receptinis	LT/1/10/1898/013	Netiekiama	-	-	No	-	-
39888	53587	1053587	flakonas	5 ml N5		Receptinis	LT/1/10/1898/014	Netiekiama	-	-	No	-	-
39889	53588	1053588	flakonas	10 ml N2		Receptinis	LT/1/10/1898/015	Netiekiama	-	-	No	-	-	Download
39890	53589	1053589	flakonas	10 ml N5		Receptinis	LT/1/10/1898/016	Netiekiama	-	-	No	-	-
52763	66697	1066697	flakonas	1 ml N1		Receptinis	LT/1/10/1898/017	Netiekiama	-	-	No	-	-
52764	66698	1066698	flakonas	5 ml N1		Receptinis	LT/1/10/1898/018	Netiekiama	-	-	No	-	-
52765	66699	1066699	flakonas	10 ml N1		Receptinis	LT/1/10/1898/019	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-05-26	Perregistruotas
2010-03-05	Registruotas