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Belgium· BE-AMP-SAM661702-00

Orkambi 75 mg - 94 mg

A ivacaftor and lumacaftor product containing lumacaftor, 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 75 mg - 94 mgATCR07AX30REGISTER NO.BE-AMP-SAM661702-00PACKS LISTED0CHECKEDSeptember 26, 2026

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

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
Lumacaftor
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 · 0

No packs listed by the register for this record.

Regulatory notes

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

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/da160f40-6907-4107-a427-ca61ef584545
GET /v1/drugs/da160f40-6907-4107-a427-ca61ef584545?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": "Granules in sachet",
  "source": "afmps",
  "status": "AUTHORIZED",
  "name_en": "Orkambi 75 mg - 94 mg",
  "name_fr": "Orkambi 75 mg - 94 mg",
  "name_nl": "Orkambi 75 mg - 94 mg",
  "amp_code": "SAM661702-00",
  "strengths": [
    "75.0000",
    "94.0000"
  ],
  "pack_count": 1,
  "substances": [
    "Lumacaftor",
    "Ivacaftor",
    "Sodium Laurilsulfate"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Ivacaftor and Lumacaftor",
  "authorisation_numbers": [
    "EU/1/15/1059/008"
  ]
}

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.