Belgium· BE-AMP-SAM661450-00

Tibsovo 250 mg

A ivosidenib product containing ivosidenib, registered in Belgium by Les Laboratoires Servier. The same ATC class is registered in 11 of our 19 countries.

ATC L01XM02

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedTibsovo 250 mgATCL01XM02REGISTER NO.BE-AMP-SAM661450-00PACKS LISTED2CHECKEDSeptember 26, 2026

Where it is registered

Ivosidenib is registered in 11 of 19 countries.

Countries holding a registration under ATC L01XM02 (ivosidenib), each read from that country’s own register.

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

Ivosidenib · ATC L01XM02

11 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Norwayprice
  • Polandprice
  • 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
Ivosidenib
Manufacturer
Les Laboratoires Servier
Country
Belgium (BE)
ATC code
L01XM02
ATC class
Ivosidenib
Defined daily dose
0.5 g, O
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 2

  • be_apb
    4696035
  • be_apb
    7741390

Regulatory notes

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

Interactions

516 interactions on record for ivosidenib.

Graded by severity as the source publishes them — 278 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

Ivosidenib · interactions on record

516 records

  • 278 severe
  • 223 moderate
  • 15 minor

Most severe, free to view

  • PapaverineA03AD01severe
  • CisaprideA03FA02severe
  • OndansetronA04AA01severe
  • GranisetronA04AA02severe
  • 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

Ivosidenib in 14 other countries

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

All ivosidenib products

Authorised across Europe · EMA

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

  • Iceland · Tibsovo
  • Liechtenstein · Tibsovo
  • Norway · Tibsovo

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/64907c3c-b370-4fc1-b81a-4a4aebbd72db
GET /v1/drugs/64907c3c-b370-4fc1-b81a-4a4aebbd72db?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": "Tibsovo 250 mg",
  "name_fr": "Tibsovo 250 mg",
  "name_nl": "Tibsovo 250 mg",
  "amp_code": "SAM661450-00",
  "strengths": [
    "250.0000",
    "250.0000",
    "9.5000"
  ],
  "pack_count": 1,
  "substances": [
    "Ivosidenib",
    "Lactose"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Ivosidenib",
  "authorisation_numbers": [
    "EU/1/23/1728/001"
  ]
}

See everything about ivosidenib.

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.