Belgium· BE-AMP-SAM560551-00

Kalydeco 25 mg

A ivacaftor product containing ivacaftor, registered in Belgium by Vertex Pharmaceuticals (Ireland). The same ATC class is registered in 17 of our 19 countries.

ATC R07AX02

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedKalydeco 25 mgATCR07AX02REGISTER NO.BE-AMP-SAM560551-00PACKS LISTED2CHECKEDSeptember 26, 2026

Where it is registered

Ivacaftor is registered in 17 of 19 countries.

Countries holding a registration under ATC R07AX02 (ivacaftor), each read from that country’s own register.

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

Ivacaftor · ATC R07AX02

17 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Germany
  • Icelandprice
  • Ireland
  • Italyprice
  • Netherlands
  • Norwayprice
  • Polandprice
  • Sweden
  • 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.

Price per daily dose

What a daily dose of ivacaftor costs, country by country.

Normalised to the WHO defined daily dose (0.3 g), the median price runs from $1.03 in France to $1826.01 in Switzerland — a ×1781 gap.

  • 3 markets with a comparable price for this class
  • Public list prices, converted to USD at the rate date shown

Ivacaftor · price per daily dose (0.3 g)

USD · FX 28 Sept 2026

  • CH Switzerland$1826.01
  • IT Italy$1090.14
  • FR France$1.03
Median listed price per WHO defined daily dose, in each market that publishes a price. Open the full comparison

The record

At a glance

FAMHP / AFMPS (Belgium)
Active substance
Ivacaftor
Manufacturer
Vertex Pharmaceuticals (Ireland)
Country
Belgium (BE)
ATC code
R07AX02
ATC class
Ivacaftor
Defined daily dose
0.3 g, O
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 2

  • be_apb
    7737083
  • be_apb
    4664546

Regulatory notes

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

Interactions

469 interactions on record for ivacaftor.

Graded by severity as the source publishes them — 80 severe. Severity grades are free for everyone; mechanism and management come with Growth.

  • Severity for every pair — free, no plan needed
  • The source, licence and sync date on every record
  • Mechanism and what to do for each pair — Growth plan

Ivacaftor · interactions on record

469 records

  • 80 severe
  • 373 moderate
  • 16 minor

Most severe, free to view

  • AprepitantA04AD12severe
  • LonafarnibA16AX20severe
  • EdoxabanB01AF03severe
  • BerotralstatB06AC06severe
  • Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

Same medicine, other countries

Ivacaftor in 16 other countries

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

All ivacaftor 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/65634004-0a79-46cc-a9b5-e477ee697dca
GET /v1/drugs/65634004-0a79-46cc-a9b5-e477ee697dca?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": "Kalydeco 25 mg",
  "name_fr": "Kalydeco 25 mg",
  "name_nl": "Kalydeco 25 mg",
  "amp_code": "SAM560551-00",
  "strengths": [
    "25.0000",
    "25.0000",
    "36.6000"
  ],
  "pack_count": 1,
  "substances": [
    "Ivacaftor",
    "Lactose Monohydrate",
    "Mannitol",
    "Sodium Laurilsulfate"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Ivacaftor",
  "authorisation_numbers": [
    "EU/1/12/782/006"
  ]
}

See everything about ivacaftor.

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.