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Ireland· IE-PA-EU/1/07/397/002-004

Siklos 100 mg film-coated tablet

A hydroxycarbamide product containing hydroxycarbamide, registered in Ireland by Theravia. The same ATC class is registered in 16 of our 19 countries.

ATC L01XX05

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedSiklos 100 mg film-coated tabletATCL01XX05REGISTER NO.IE-PA-EU/1/07/397/002…PACKS LISTED1CHECKEDSeptember 28, 2026

Where it is registered

Hydroxycarbamide is registered in 16 of 19 countries.

Countries holding a registration under ATC L01XX05 (hydroxycarbamide), each read from that country’s own register.

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

Hydroxycarbamide · ATC L01XX05

16 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Germany
  • Icelandprice
  • Ireland
  • Italyprice
  • 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 hydroxycarbamide costs, country by country.

Normalised to the WHO defined daily dose (1.4 g), the median price runs from $0.51 in United States to $16.83 in France — a ×33 gap.

  • 4 markets with a comparable price for this class
  • Public list prices, converted to USD at the rate date shown
  • US figures are pharmacy acquisition cost (CMS NADAC), not retail

Hydroxycarbamide · price per daily dose (1.4 g)

USD · FX 28 Sept 2026

  • FR France$16.83
  • CH Switzerland$2.74
  • IT Italy$1.13
  • US United States$0.51 (acquisition cost)
Median listed price per WHO defined daily dose, in each market that publishes a price. US = pharmacy acquisition cost (CMS NADAC), not a retail price. Open the full comparison

The record

At a glance

HPRA (Ireland)
Active substance
Hydroxycarbamide
Manufacturer
Theravia
Country
Ireland (IE)
ATC code
L01XX05
ATC class
Hydroxycarbamide
Defined daily dose
1.4 g, O
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    EU/1/07/397/002-004

Regulatory notes

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

Interactions

333 interactions on record for hydroxycarbamide.

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

Hydroxycarbamide · interactions on record

333 records

  • 31 severe
  • 101 moderate
  • 15 minor
  • 186 info

Most severe, free to view

  • DidanosineJ05AF02severe
  • CladribineL01BB04severe
  • Talimogene laherparepvecL01XL02severe
  • Talimogen laherparepvecL01XX51severe
  • 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

Hydroxycarbamide in 16 other countries

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

All hydroxycarbamide products

Authorised across Europe · EMA

The same active substance is authorised in 30 EEA countries. Names it is sold under:

  • Austria · Ardjaq, Hydroxycarbamid Devatis
  • Belgium · Hydrea
  • Bulgaria · Хидреа
  • Cyprus · Hydreasyn
  • Czechia · Litalir
  • Germany · Ardjaq, Hydroxycarbamid 1 A Pharma
  • Denmark · Hydroxyurea Medac, Oribamide
  • Estonia · Hydrea
  • Spain · Hidroxicarbamida Hikma, Hidroxicarbamida Medac
  • Finland · Hydrea, Hydroxyurea Medac
  • France · Hydrea, Hydroxycarbamide Arrow
  • United Kingdom (Northern Ireland) · Hydrea, Hydroxycarbamide
  • Greece · Hydreasyn
  • Croatia · Litalir, Xybaid
  • Hungary · Hydroxycarbamide Pharmacenter, Litalir
  • Iceland · Hydroxyurea Medac, Siklos
  • Italy · Idrossicarbamide Aurobindo, Onco Carbide
  • Liechtenstein · Siklos
  • Lithuania · Hydrea
  • Luxembourg · Hydrea, Hydroxycarbamid Devatis
  • Latvia · Hydrea
  • Malta · Hydroxycarbamide Eugia
  • Netherlands · Hydroxycarbamide Devatis, Hydroxycarbamide Eugia
  • Norway · Hydroxyurea Medac, Oribamide
  • Poland · Hydroxycarbamid Eugia, Hydroxycarbamid Teva
  • Portugal · Hidroxicarbamida Generis, Hidroxicarbamida Hikma
  • Romania · Hydrea
  • Sweden · Hydrea, Hydroxyurea Medac
  • Slovenia · Hidroksisečnina Aptapharma, Litalir
  • Slovakia · Hydroxykarbamid Medac, Xybaid

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/ad2f948c-9974-4004-a86d-03be41a82cf5
GET /v1/drugs/ad2f948c-9974-4004-a86d-03be41a82cf5?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": "Film-coated tablet",
  "routes": [
    "Oral use"
  ],
  "source": "hpra",
  "atc_all": [
    "L01XX",
    "L01XX05"
  ],
  "strength": null,
  "pa_number": "EU/1/07/397/002-004",
  "substances": [
    "Hydroxycarbamide"
  ],
  "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
  "market_info": "Unknown",
  "authorised_at": "28/02/2011",
  "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 hydroxycarbamide.

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.