MONOFER

This brand name is authorized in Australia, Austria, Brazil, Croatia, Estonia, Finland, Hong Kong SAR China, Lithuania, Netherlands, New Zealand, Romania, Singapore, South Africa, UK.

Active ingredients

The drug MONOFER contains one active pharmaceutical ingredient (API):

1	Iron (III) isomaltoside UNII 3M6325NY1R - IRON ISOMALTOSIDE 1000
	Iron(III) complex enables a controlled and slow release of bioavailable iron to iron-binding proteins with little risk of free iron. Evidence of a therapeutic response can be seen within a few days of administration of iron(III) as an increase in the reticulocyte count.
	Read more about Iron (III) isomaltoside

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
MONOFER Solution for injection / infusion	MPI, EU: SmPC	Medicines & Healthcare Products Regulatory Agency (GB)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group		Classification
B03AC	Iron trivalent, parenteral preparations	B Blood and blood forming organs → B03 Antianemic preparations → B03A Iron preparations
Discover more medicines within B03AC

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
AU	Pharmaceutical Benefits Scheme	11615H, 12049E
BR	Câmara de Regulação do Mercado de Medicamentos	522720090089807, 522720090089907
EE	Ravimiamet	1357208, 1357219, 1357220, 1357231, 1357242, 1357253, 1357264, 1357275, 1585278, 1585289, 1585290
FI	Lääkealan turvallisuus- ja kehittämiskeskus	089801, 089913, 089936
GB	Medicines & Healthcare Products Regulatory Agency	180231, 180235, 180239
HK	Department of Health Drug Office	61623, 61624, 61625
HR	Agencija za lijekove i medicinske proizvode	HR-H-258767229
LT	Valstybinė vaistų kontrolės tarnyba	1032978, 1033324, 1033325, 1033326, 1033327, 1053579, 1053580, 1053581, 1053582, 1053583, 1053584, 1053585, 1053586, 1053587, 1053588, 1053589, 1066697, 1066698, 1066699
NL	Z-Index G-Standaard, PRK	95095, 95109, 95117
NZ	Medicines and Medical Devices Safety Authority	20373, 20374, 20375, 20376
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W55306001, W55306002, W55306003, W55306004, W55306005, W55306006, W55306007, W55306008, W55306009, W55306010, W55306011, W55306012, W55306013, W55306014, W55306015, W55306016, W55306017, W55306018, W55306019
SG	Health Sciences Authority	15855P
ZA	Health Products Regulatory Authority	46/8.3/0166, 46/8.3/0167, 46/8.3/0168