MONOFER

This brand name is authorized in Austria, Australia, Brazil, Estonia, Finland, Hong Kong, Croatia, Lithuania, Netherlands, New Zealand, Romania, Singapore, United Kingdom, South Africa

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 about Iron (III) isomaltoside

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

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