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Ireland· IE-PA-EU/1/96/027/003

Hycamtin 4 mg powder for concentrate for solution for infusion

A topotecan product containing topotecan hydrochloride, registered in Ireland by Sandoz Pharmaceuticals d.d.. The same ATC class is registered in 4 of our 19 countries.

ATC L01XX17

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedHycamtin 4 mg powder for concentrate …ATCL01XX17REGISTER NO.IE-PA-EU/1/96/027/003PACKS LISTED1CHECKEDSeptember 28, 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: Ireland, from HPRA (Ireland)
  • 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

HPRA (Ireland)
Active substance
Topotecan hydrochloride
Manufacturer
Sandoz Pharmaceuticals d.d.
Country
Ireland (IE)
ATC code
L01XX17
ATC class
Topotecan
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    EU/1/96/027/003

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
  • Belgium · Topotecan Accord Healthcare
  • 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
  • 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 HPRA (Ireland). 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/6dcaa09a-a5f2-46da-a9a0-aac0967c932f
GET /v1/drugs/6dcaa09a-a5f2-46da-a9a0-aac0967c932f?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": "Powder for concentrate for solution for infusion",
  "routes": null,
  "source": "hpra",
  "atc_all": [
    "L01XX",
    "L01XX17"
  ],
  "strength": null,
  "pa_number": "EU/1/96/027/003",
  "substances": [
    "Topotecan hydrochloride"
  ],
  "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
  "market_info": "Unknown",
  "authorised_at": "15/04/1997",
  "dispensing_status": "Product subject to prescription which may not be renewed (A)",
  "registration_status": "AU",
  "supply_legal_status": "Supply through pharmacies only",
  "interchangeable_code": null
}
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