Belgium· BE-AMP-SAM516400-00

Mavenclad 10 mg

A cladribine product containing cladribine, registered in Belgium by Merck Europe. The same ATC class is registered in 12 of our 19 countries.

ATC L04AA40

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedMavenclad 10 mgATCL04AA40REGISTER NO.BE-AMP-SAM516400-00PACKS LISTED5CHECKEDSeptember 26, 2026

Where it is registered

Cladribine is registered in 12 of 19 countries.

Countries holding a registration under ATC L04AA40 (cladribine), 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

Cladribine · ATC L04AA40

12 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Germany
  • 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.

Price per daily dose

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

Normalised to the WHO defined daily dose (0.34 mg), the median price runs from $0.048 in France to $90.83 in Switzerland — a ×1908 gap.

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

Cladribine · price per daily dose (0.34 mg)

USD · FX 28 Sept 2026

  • CH Switzerland$90.83
  • FR France$0.048
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
Cladribine
Manufacturer
Merck Europe
Country
Belgium (BE)
ATC code
L04AA40
ATC class
Cladribine
Defined daily dose
0.34 mg, O
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 5

  • be_apb
    3678091
  • be_apb
    7722937
  • be_apb
    3677804
  • be_apb
    3677812
  • be_apb
    4200481

Regulatory notes

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

Interactions

409 interactions on record for cladribine.

Graded by severity as the source publishes them — 326 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

Cladribine · interactions on record

409 records

  • 326 severe
  • 79 moderate
  • 4 info

Most severe, free to view

  • PrednisoloneA07EA01severe
  • HydrocortisoneA07EA02severe
  • PrednisoneA07EA03severe
  • BetamethasoneA07EA04severe
  • 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

Cladribine in 16 other countries

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

All cladribine products

Authorised across Europe · EMA

The same active substance is authorised in 22 EEA countries. Names it is sold under:

  • Austria · Leuject
  • Bulgaria · Леуджект
  • Czechia · Leuject
  • Germany · Leustatin
  • Spain · Leustatin
  • Finland · Leuject
  • France · Leustatine
  • United Kingdom (Northern Ireland) · Cladribine Zentiva, Leustat
  • Greece · Leustatin
  • Croatia · Leuject
  • Hungary · Leuject
  • Iceland · Mavenclad
  • Italy · Leustatin
  • Liechtenstein · Mavenclad
  • Luxembourg · Leustatin
  • Netherlands · Leustatin
  • Norway · Leuject, Mavenclad
  • Poland · Biodribin, Leuject
  • Portugal · Cladribina Generis, Leustatin
  • Romania · Leuject
  • Sweden · Leuject
  • Slovenia · Leuject

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/b59baac7-225f-4ad1-a9b5-9b8226bb759b
GET /v1/drugs/b59baac7-225f-4ad1-a9b5-9b8226bb759b?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": "Tablet",
  "source": "afmps",
  "status": "AUTHORIZED",
  "name_en": "Mavenclad 10 mg",
  "name_fr": "Mavenclad 10 mg",
  "name_nl": "Mavenclad 10 mg",
  "amp_code": "SAM516400-00",
  "strengths": [
    "10.0000",
    "64.0000"
  ],
  "pack_count": 10,
  "substances": [
    "Cladribine",
    "Hydroxypropylbetadex",
    "Sorbitol"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Cladribine",
  "authorisation_numbers": [
    "EU/1/17/1212/002",
    "EU/1/17/1212/001",
    "EU/1/17/1212/004",
    "EU/1/17/1212/003",
    "EU/1/17/1212/006",
    "EU/1/17/1212/005"
  ]
}

See everything about cladribine.

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.