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Belgium· BE-AMP-SAM384063-00

Topotecan Mylan 1 mg/ml

A topotecan product containing topotecan hydrochloride, registered in Belgium by Viatris GX. The same ATC class is registered in 4 of our 19 countries.

ATC L01XX17

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedTopotecan Mylan 1 mg/mlATCL01XX17REGISTER NO.BE-AMP-SAM384063-00PACKS LISTED1CHECKEDSeptember 26, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about topotecan hydrochlorideAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Topotecan is registered in 4 of 19 countries.

Countries holding a registration under ATC L01XX17 (topotecan), each read from that country’s own register.

  • This record: Belgium, from FAMHP / AFMPS (Belgium)
  • 3 of them publish a price we can compare per daily dose
Search topotecan products by name

Topotecan · ATC L01XX17

4 / 19 countries

  • Belgiumprice
  • Ireland
  • Polandprice
  • Switzerlandprice
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
Topotecan Hydrochloride
Manufacturer
Viatris GX
Country
Belgium (BE)
ATC code
L01XX17
ATC class
Topotecan
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 1

  • be_apb
    2907244

Regulatory notes

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

Interactions

348 interactions on record for topotecan.

Graded by severity as the source publishes them — 31 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
Check topotecan against other medicinesHow interaction checks work

Topotecan · interactions on record

348 records

  • 31 severe
  • 277 moderate
  • 16 minor
  • 24 info

Most severe, free to view

  • CisplatinL01XA01severe
  • CarboplatinL01XA02severe
  • OxaliplatinL01XA03severe
  • RolapitantA04AD14moderate
  • 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

Topotecan in 16 other countries

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

All topotecan products

Authorised across Europe · EMA

The same active substance is authorised in 29 EEA countries. Names it is sold under:

  • Austria · Topotecan Accord, Topotecan Ebewe
  • Bulgaria · Топотекан Акорд
  • Cyprus · Topotecan Accord, Topotecan Venus
  • Czechia · Topotecan Accord
  • Germany · Topotecan Accord, Topotecan Hexal
  • Denmark · Topotecan "ebewe", Topotecan Accord
  • Estonia · Topotecan Accord
  • Spain · Topotecán Accord
  • Finland · Topotecan Accord, Topotecan Ebewe
  • France · Topotecane Accord
  • United Kingdom (Northern Ireland) · Topotecan Accord Healthcare, Topotecan Sandoz
  • Greece · Topocan, Topotecan Accord
  • Croatia · Topotekan Alpha-Medical
  • Hungary · Topotecan Accord
  • Ireland · Topotecan Accord
  • Iceland · Hycamtin, Potactasol
  • Italy · Topotecan Ahcl
  • Liechtenstein · Hycamtin, Hycamtin 4 Mg Powder For Concentrate For Solution For Infusion
  • Lithuania · Topotecan Accord
  • Luxembourg · Topotecan Accord Healthcare
  • Latvia · Topotecan Ahcl
  • Netherlands · Topotecan Accord, Topotecan Hikma
  • Norway · Hycamtin, Potactasol
  • Poland · Topotecanum Accord
  • Portugal · Topotecano Accord, Topotecano Azevedos
  • Romania · Topotecan Accord
  • Sweden · Topotecan Accord, Topotecan Ebewe
  • Slovenia · Topotekan Accord
  • Slovakia · Topotecan Accord

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/33049a8c-f4e2-4677-92e4-f0aeb5afc095
GET /v1/drugs/33049a8c-f4e2-4677-92e4-f0aeb5afc095?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": "REVOKED",
  "name_en": "Topotecan Mylan 1 mg/ml",
  "name_fr": "Topotecan Mylan 1 mg/ml",
  "name_nl": "Topotecan Mylan 1 mg/ml",
  "amp_code": "SAM384063-00",
  "strengths": [
    "1.0870",
    "1.0000"
  ],
  "pack_count": 3,
  "substances": [
    "Topotecan Hydrochloride",
    "Topotecan"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Topotecan",
  "authorisation_numbers": [
    "BE384063"
  ]
}
API referenceMCP serverPlans

See everything about topotecan.

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