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Ireland· IE-PA-EU/1/10/622/001

TEPADINA 15 mg powder for concentrate for solution for infusion

A thiotepa product containing thiotepa, registered in Ireland by Adienne S.r.l.. The same ATC class is registered in 16 of our 19 countries.

ATC L01AC01

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedTEPADINA 15 mg powder for concentrate…ATCL01AC01REGISTER NO.IE-PA-EU/1/10/622/001PACKS LISTED1CHECKEDSeptember 28, 2026

Where it is registered

Thiotepa is registered in 16 of 19 countries.

Countries holding a registration under ATC L01AC01 (thiotepa), each read from that country’s own register.

  • This record: Ireland, from HPRA (Ireland)
  • 9 of them publish a price we can compare per daily dose

Thiotepa · ATC L01AC01

16 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Germany
  • Icelandprice
  • Ireland
  • Netherlands
  • Norwayprice
  • Polandprice
  • Sweden
  • 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

HPRA (Ireland)
Active substance
Thiotepa
Manufacturer
Adienne S.r.l.
Country
Ireland (IE)
ATC code
L01AC01
ATC class
Thiotepa
Defined daily dose
1.62 g, P
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    EU/1/10/622/001

Regulatory notes

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

Interactions

202 interactions on record for thiotepa.

Graded by severity as the source publishes them — 43 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

Thiotepa · interactions on record

202 records

  • 43 severe
  • 105 moderate
  • 14 minor
  • 40 info

Most severe, free to view

  • Nalidixic acidJ01MB02severe
  • CyclophosphamideL01AA01severe
  • ChlorambucilL01AA02severe
  • MelphalanL01AA03severe
  • 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

Thiotepa in 16 other countries

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

All thiotepa products

Authorised across Europe · EMA

The same active substance is authorised in 26 EEA countries. Names it is sold under:

  • Austria · Thiotepa Fresenius Kabi
  • Belgium · Thiotepa Fresenius Kabi
  • Bulgaria · Тиотепа Msn
  • Czechia · Thiotepa Fresenius Kabi, Thiotepa Msn
  • Germany · Thionovia, Thiotepa Fresenius Kabi
  • Denmark · Thiotepa Abcur, Thiotepa Fresenius Kabi
  • Estonia · Thiotepa Fresenius Kabi, Thiotepa Msn
  • Spain · Thionovia, Thiotepa Vivanta
  • Finland · Thiotepa Abcur, Thiotepa Fresenius Kabi
  • France · Thionovia, Thiotepa Fresenius Kabi
  • United Kingdom (Northern Ireland) · Thiotepa, Thiotepa Hikma Farmacêutica (Portugal)
  • Croatia · Tiotepa Fresenius Kabi, Tiotepa Msn
  • Hungary · Thiotepa, Thiotepa Medac
  • Iceland · Tepadina, Thiotepa Abcur
  • Italy · Thionovia, Thiotepa Medac
  • Liechtenstein · Tepadina, Thiotepa Riemser
  • Lithuania · Thiotepa Fresenius Kabi, Thiotepa Msn
  • Latvia · Thiotepa Fresenius Kabi, Thiotepa Msn
  • Netherlands · Thiotepa Fresenius Kabi, Thiotepa Medac
  • Norway · Tepadina, Thiotepa Abcur
  • Poland · Thiotepa Fresenius Kabi, Thiotepa Msn
  • Portugal · Tiotepa Fresenius Kabi, Tiotepa Hikma
  • Romania · Thiotepa Fresenius Kabi, Thiotepa Msn
  • Sweden · Thionovia, Thiotepa Abcur
  • Slovenia · Thiotepa Msn
  • Slovakia · Thiotepa Fresenius Kabi, Thiotepa Msn

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/083a732f-a3d7-4551-a00e-d004d62f84aa
GET /v1/drugs/083a732f-a3d7-4551-a00e-d004d62f84aa?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": [
    "Intravenous use"
  ],
  "source": "hpra",
  "atc_all": [
    "L01AC",
    "L01AC01"
  ],
  "strength": null,
  "pa_number": "EU/1/10/622/001",
  "substances": [
    "Thiotepa"
  ],
  "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)",
  "market_info": "Unknown",
  "authorised_at": "15/03/2010",
  "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
}

See everything about thiotepa.

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.