Belgium· BE-AMP-SAM591084-00

Koselugo 10 mg

A selumetinib product containing selumetinib hydrogen sulfate, registered in Belgium by AstraZeneca. The same ATC class is registered in 16 of our 19 countries.

ATC L01EE04

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedKoselugo 10 mgATCL01EE04REGISTER NO.BE-AMP-SAM591084-00PACKS LISTED1CHECKEDSeptember 26, 2026

Where it is registered

Selumetinib is registered in 16 of 19 countries.

Countries holding a registration under ATC L01EE04 (selumetinib), 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

Selumetinib · ATC L01EE04

16 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Icelandprice
  • Ireland
  • Japan
  • 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.

Price per daily dose

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

Normalised to the WHO defined daily dose (50 mg), so markets compare like for like.

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

Selumetinib · price per daily dose (50 mg)

USD · FX 28 Sept 2026

  • CH Switzerland$482.52
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
Selumetinib Hydrogen Sulfate
Manufacturer
AstraZeneca
Country
Belgium (BE)
ATC code
L01EE04
ATC class
Selumetinib
Defined daily dose
50 mg, O
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 1

  • be_apb
    4441093

Regulatory notes

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

Interactions

111 interactions on record for selumetinib.

Graded by severity as the source publishes them — 30 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

Selumetinib · interactions on record

111 records

  • 30 severe
  • 81 moderate

Most severe, free to view

  • AprepitantA04AD12severe
  • DexamethasoneH02AB02severe
  • KetoconazoleH02CA03severe
  • ChloramphenicolJ01BA01severe
  • 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

Selumetinib in 14 other countries

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

All selumetinib products

Authorised across Europe · EMA

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

  • Iceland · Koselugo
  • Liechtenstein · Koselugo
  • Norway · Koselugo

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/810a5d99-22dc-47d9-9e6e-71fbb53a34ee
GET /v1/drugs/810a5d99-22dc-47d9-9e6e-71fbb53a34ee?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": "Capsule, hard",
  "source": "afmps",
  "status": "AUTHORIZED",
  "name_en": "Koselugo 10 mg",
  "name_fr": "Koselugo 10 mg",
  "name_nl": "Koselugo 10 mg",
  "amp_code": "SAM591084-00",
  "strengths": [
    "10.0000"
  ],
  "pack_count": 1,
  "substances": [
    "Selumetinib Hydrogen Sulfate",
    "Selumetinib",
    "Potassium Chloride",
    "Propylene Glycol"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Selumetinib",
  "authorisation_numbers": [
    "EU/1/21/1552/001"
  ]
}

See everything about selumetinib.

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.