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Belgium· BE-AMP-SAM543653-00

Libtayo 350 mg

A cemiplimab product containing cemiplimab, registered in Belgium by Regeneron Ireland Designated Activity Company (DAC). The same ATC class is registered in 12 of our 19 countries.

ATC L01FF06

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedLibtayo 350 mgATCL01FF06REGISTER NO.BE-AMP-SAM543653-00PACKS LISTED3CHECKEDSeptember 26, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about cemiplimabAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Cemiplimab is registered in 12 of 19 countries.

Countries holding a registration under ATC L01FF06 (cemiplimab), 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
Search cemiplimab products by name

Cemiplimab · ATC L01FF06

12 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Netherlands
  • 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
Cemiplimab
Manufacturer
Regeneron Ireland Designated Activity Company (DAC)
Country
Belgium (BE)
ATC code
L01FF06
ATC class
Cemiplimab
Defined daily dose
16.7 mg, P
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 3

  • be_apb
    7729684
  • be_apb
    4105052
  • be_apb
    4309456

Regulatory notes

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

Interactions

17 interactions on record for cemiplimab.

Graded by severity as the source publishes them — 17 moderate. 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
Check cemiplimab against other medicinesHow interaction checks work

Cemiplimab · interactions on record

17 records

  • 17 moderate

Most severe, free to view

  • PrednisoloneA07EA01moderate
  • HydrocortisoneA07EA02moderate
  • PrednisoneA07EA03moderate
  • BetamethasoneA07EA04moderate
  • 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

Cemiplimab in 15 other countries

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

All cemiplimab products

Authorised across Europe · EMA

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

  • Iceland · Libtayo
  • Liechtenstein · Libtayo
  • Norway · Libtayo

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/b9ee9834-29cb-45aa-93b7-3ee5aa320340
GET /v1/drugs/b9ee9834-29cb-45aa-93b7-3ee5aa320340?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": "Concentrate for solution for infusion",
  "source": "afmps",
  "status": "AUTHORIZED",
  "name_en": "Libtayo 350 mg",
  "name_fr": "Libtayo 350 mg",
  "name_nl": "Libtayo 350 mg",
  "amp_code": "SAM543653-00",
  "strengths": [
    "50.0000"
  ],
  "pack_count": 3,
  "substances": [
    "Cemiplimab",
    "Proline",
    "Sucrose",
    "Polysorbate 80"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Cemiplimab",
  "authorisation_numbers": [
    "EU/1/19/1376/001"
  ]
}
API referenceMCP serverPlans

See everything about cemiplimab.

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.

Try it freeOpen in the console