Belgium· BE-AMP-SAM577386-00
Monoferric 100 mg/ml
A iron, parenteral preparations product containing ferric derisomaltose, registered in Belgium by Pharmacosmos. The same ATC class is registered in 11 of our 19 countries.
Checked against FAMHP / AFMPS (Belgium) on
Informational only — not a medical device.
Where it is registered
Ferric derisomaltose is registered in 11 of 19 countries.
Countries holding a registration under ATC B03AC (iron, parenteral preparations), each read from that country’s own register.
- This record: Belgium, from FAMHP / AFMPS (Belgium)
- 7 of them publish a price we can compare per daily dose
Ferric derisomaltose · ATC B03AC
11 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
The record
At a glance
FAMHP / AFMPS (Belgium)- Active substance
- Ferric Derisomaltose
- Manufacturer
- Pharmacosmos
- Country
- Belgium (BE)
- ATC code
- B03AC
- ATC class
- Iron, parenteral preparations
- Reimbursed
- Not published by this register
- Source register
- FAMHP / AFMPS (Belgium)
- Last checked
- September 26, 2026
Packs & prices · 2
- be_apb4493755
- be_apb7734072
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Ferric derisomaltose in 10 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- SwedenMonofer 100 mg/ml Injektions-/infusionsvätska, lösningMedartuum AB
- United StatesMonoferricPharmacosmos Therapeutics Inc.
- FinlandMonoferPharmacosmos A/S
- IcelandMonoferPharmacosmos A/S*
- NorwayMonoferPharmacosmos
- United KingdomDiafer 100mg/2ml solution for injection ampoulesPharmacosmos UK Ltd
- Japanデルイソマルトース第二鉄日本新薬
- NetherlandsDiafer 50 mg/ml oplossing voor injectiePharmacosmos A/S
Authorised across Europe · EMA
The same active substance is authorised in 21 EEA countries. Names it is sold under:
- Austria · Monofer
- Bulgaria · Монофер
- Germany · Monofer
- Denmark · Diafer, Monofer
- Estonia · Monofer
- Finland · Diafer, Monofer
- United Kingdom (Northern Ireland) · Diafer, Monofer
- Croatia · Monofer
- Ireland · Diafer, Monover
- Iceland · Monofer
- Italy · Monoferric
- Lithuania · Monofer
- Luxembourg · Monover
- Latvia · Monofer
- Netherlands · Diafer, Monofer
- Norway · Diafer, Monofer
- Poland · Diafer, Monover
- Portugal · Monofar
- Romania · Diafer, Monofer
- Sweden · Diafer, Monofer
- Slovenia · Monofer
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FAMHP / AFMPS (Belgium). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/001c4c2e-bd80-487f-863d-a515860ed385 GET /v1/drugs/001c4c2e-bd80-487f-863d-a515860ed385?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"form": "Solution for injection/infusion",
"source": "afmps",
"status": "AUTHORIZED",
"name_en": "Monoferric 100 mg/ml",
"name_fr": "Monoferric 100 mg/ml",
"name_nl": "Monoferric 100 mg/ml",
"amp_code": "SAM577386-00",
"strengths": [
"417.0000",
"100.0000"
],
"pack_count": 3,
"substances": [
"Ferric Derisomaltose",
"Iron",
"Sodium Hydroxide"
],
"medicine_type": "ALLOPATHIC",
"atc_description": "Iron, Parenteral Preparations",
"authorisation_numbers": [
"BE577386"
]
}See everything about ferric derisomaltose.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.