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Belgium· BE-AMP-SAM663138-00

Rystiggo 140 mg/ml

A rozanolixizumab product containing rozanolixizumab, registered in Belgium by UCB Pharma. The same ATC class is registered in 7 of our 19 countries.

ATC L04AL02

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedRystiggo 140 mg/mlATCL04AL02REGISTER NO.BE-AMP-SAM663138-00PACKS LISTED2CHECKEDSeptember 26, 2026

Where it is registered

Rozanolixizumab is registered in 7 of 19 countries.

Countries holding a registration under ATC L04AL02 (rozanolixizumab), each read from that country’s own register.

  • This record: Belgium, from FAMHP / AFMPS (Belgium)
  • 5 of them publish a price we can compare per daily dose

Rozanolixizumab · ATC L04AL02

7 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • United Kingdom
  • United Statesprice
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
Rozanolixizumab
Manufacturer
UCB Pharma
Country
Belgium (BE)
ATC code
L04AL02
ATC class
Rozanolixizumab
Defined daily dose
80 mg, P
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 2

  • be_apb
    4873055
  • be_apb
    7746860

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Same medicine, other countries

Rozanolixizumab in 13 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All rozanolixizumab products

Authorised across Europe · EMA

The same active substance is authorised in 3 EEA countries. Names it is sold under:

  • Iceland · Rystiggo
  • Liechtenstein · Rystiggo
  • Norway · Rystiggo

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/807b6d71-ff1c-4623-8621-0dd69b8bbdd4
GET /v1/drugs/807b6d71-ff1c-4623-8621-0dd69b8bbdd4?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",
  "source": "afmps",
  "status": "AUTHORIZED",
  "name_en": "Rystiggo 140 mg/ml",
  "name_fr": "Rystiggo 140 mg/ml",
  "name_nl": "Rystiggo 140 mg/ml",
  "amp_code": "SAM663138-00",
  "strengths": [
    "140.0000",
    "140.0000",
    "29.0000"
  ],
  "pack_count": 1,
  "substances": [
    "Rozanolixizumab",
    "Proline",
    "Polysorbate 80"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Rozanolixizumab",
  "authorisation_numbers": [
    "EU/1/23/1780/002"
  ]
}

See everything about rozanolixizumab.

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.