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Belgium· BE-AMP-SAM577377-00

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.

ATC B03AC

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedMonoferric 100 mg/mlATCB03ACREGISTER NO.BE-AMP-SAM577377-00PACKS LISTED0CHECKEDSeptember 26, 2026

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
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

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 · 0

No packs listed by the register for this record.

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.

All ferric derisomaltose products

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/c615c9b3-3259-457b-9a9e-a387ea3bee0a
GET /v1/drugs/c615c9b3-3259-457b-9a9e-a387ea3bee0a?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": "SAM577377-00",
  "strengths": [
    "417.0000",
    "100.0000"
  ],
  "pack_count": 2,
  "substances": [
    "Ferric Derisomaltose",
    "Iron",
    "Sodium Hydroxide"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Iron, Parenteral Preparations",
  "authorisation_numbers": [
    "BE577377"
  ]
}

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.