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Belgium· BE-AMP-SAM485111-00

Orkambi 200 mg - 125 mg

A ivacaftor and lumacaftor product containing ivacaftor, registered in Belgium by Vertex Pharmaceuticals (Ireland). The same ATC class is registered in 16 of our 19 countries.

ATC R07AX30

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedOrkambi 200 mg - 125 mgATCR07AX30REGISTER NO.BE-AMP-SAM485111-00PACKS LISTED1CHECKEDSeptember 26, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about ivacaftorAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Ivacaftor and lumacaftor is registered in 16 of 19 countries.

Countries holding a registration under ATC R07AX30 (ivacaftor and lumacaftor), each read from that country’s own register.

  • This record: Belgium, from FAMHP / AFMPS (Belgium)
  • 11 of them publish a price we can compare per daily dose
Search ivacaftor and lumacaftor products by name

Ivacaftor and lumacaftor · ATC R07AX30

16 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Icelandprice
  • Ireland
  • Italyprice
  • Netherlands
  • Norwayprice
  • Polandprice
  • Spainprice
  • Switzerlandprice
  • 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
Ivacaftor
Manufacturer
Vertex Pharmaceuticals (Ireland)
Country
Belgium (BE)
ATC code
R07AX30
ATC class
Ivacaftor and lumacaftor
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 1

  • be_apb
    3479011

Regulatory notes

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

Same medicine, other countries

Ivacaftor and lumacaftor in 16 other countries

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

All ivacaftor and lumacaftor products

Authorised across Europe · EMA

The same active substance is authorised in 27 EEA countries. Names it is sold under:

  • Austria · Ivacaftor Accord, Ivacaftor Stada
  • Cyprus · Vaftor
  • Czechia · Ivacaftor Accord
  • Germany · Ivacaftor Al, Ivacaftor Basics
  • Denmark · Ivacaftor "stada", Ivacaftor Accord
  • Estonia · Ivacaftor Stada
  • Spain · Ivacaftor Accord, Ivacaftor Aurovitas
  • Finland · Ivacaftor Accord, Ivacaftor Stada Stada
  • France · Ivacaftor Accord, Ivacaftor Arrow
  • United Kingdom (Northern Ireland) · Ivacaftor Lupin Healthcare (Uk)
  • Greece · Ivacaftor Win Medica, Qulventra
  • Croatia · Ivacaftor Accord, Ivakaftor Galenika
  • Hungary · Ivacaftor Galenika, Ivacaftor Stada
  • Iceland · Kalydeco
  • Italy · Ivacaftor Accord, Ivacaftor Sun
  • Liechtenstein · Kalydeco
  • Lithuania · Ivacaftor Stada
  • Luxembourg · Ivacaftor Ab, Ivacaftor Eg
  • Latvia · Ivacaftor Stada, Ivacaftor Teva
  • Malta · Fidasercot, Flidepartoc
  • Netherlands · Ivacaftor Aurobindo, Ivacaftor Intas
  • Norway · Ivacaftor Accord, Ivacaftor Lupin Europe Gmbh
  • Poland · Ivacaftor Accord, Ivacaftor Ranbaxy
  • Portugal · Ivacaftor Accord, Ivacaftor Generis
  • Romania · Ivacaftor Stada, Ivacaftor Sun
  • Sweden · Fidasercot, Flidepartoc
  • Slovenia · Ivakaftor Accord, Ivakaftor Galenika

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/ed6c1d3d-7509-44dc-94da-7630130682b8
GET /v1/drugs/ed6c1d3d-7509-44dc-94da-7630130682b8?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": "Film-coated tablet",
  "source": "afmps",
  "status": "AUTHORIZED",
  "name_en": "Orkambi 200 mg - 125 mg",
  "name_fr": "Orkambi 200 mg - 125 mg",
  "name_nl": "Orkambi 200 mg - 125 mg",
  "amp_code": "SAM485111-00",
  "strengths": [
    "125.0000",
    "125.0000",
    "200.0000",
    "200.0000"
  ],
  "pack_count": 3,
  "substances": [
    "Ivacaftor",
    "Lumacaftor",
    "Propylene Glycol",
    "Sodium Laurilsulfate"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Ivacaftor and Lumacaftor",
  "authorisation_numbers": [
    "EU/1/15/1059/001",
    "EU/1/15/1059/002",
    "EU/1/15/1059/003"
  ]
}
API referenceMCP serverPlans

See everything about ivacaftor and lumacaftor.

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.

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