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

UAB Niromed, Lietuva

Date of authorisation

2026-06-19

Date of renewal

Documents

3491_MonoFer inj_PIL_2026-06-19.docx

3491_MonoFer inj_PZ_2026-06-19.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Lygiagretus importas

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
121444	107551	1107551	flakonas	1 ml N1		Receptinis	LT/L/26/3491/001	Tiekiama	2026-08-15	-	No	-	-
121445	107552	1107552	flakonas	1 ml N2		Receptinis	LT/L/26/3491/002	Netiekiama	-	-	No	-	-
121446	107553	1107553	flakonas	1 ml N3		Receptinis	LT/L/26/3491/003	Netiekiama	-	-	No	-	-
121447	107554	1107554	flakonas	1 ml N5		Receptinis	LT/L/26/3491/004	Netiekiama	-	-	No	-	-	Download
121448	107555	1107555	flakonas	1 ml N10		Receptinis	LT/L/26/3491/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2026-06-19	Registruotas