Ireland· IE-PA-EU/1/13/839/003-004
Iclusig 45 mg film-coated tablets
A ponatinib product containing ponatinib hci, registered in Ireland by Incyte Biosciences Distribution B.V..
Checked against HPRA (Ireland) on
Informational only — not a medical device.
The record
At a glance
HPRA (Ireland)- Active substance
- Ponatinib hci
- Manufacturer
- Incyte Biosciences Distribution B.V.
- Country
- Ireland (IE)
- ATC code
- L01XE24
- ATC class
- Ponatinib
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/13/839/003-004
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
500 interactions on record for ponatinib.
Graded by severity as the source publishes them — 166 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
Ponatinib · interactions on record
500 records
- 166 severe
- 303 moderate
- 31 minor
Most severe, free to view
- LonafarnibA16AX20severe
- DicoumarolB01AA01severe
- WarfarinB01AA03severe
- HeparinB01AB01severe
- 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.
Same medicine, other countries
Ponatinib in 14 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- SwitzerlandIclusig
- CzechiaICLUSIGIncyte Biosciences Distribution B.V., Amsterdam
- United StatesIclusigTakeda Pharmaceuticals America, Inc.
- FranceICLUSIG 45 mg, comprimés pelliculésINCYTE BIOSCIENCES DISTRIBUTION (PAYS-BAS)
- BelgiumIclusig 45 mgIncyte Biosciences Distribution
- NetherlandsIclusig 45 mg, filmomhulde tabletIncyte Biosciences Distribution B.V.
- NorwayIclusigIncyte Biosciences Distribution B.V.
- PolandIclusigIncyte Biosciences Distribution B.V.
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Iclusig
- Liechtenstein · Iclusig
- Norway · Iclusig
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/8ba77fd0-07d8-4ba8-9ae5-8e7670c93065 GET /v1/drugs/8ba77fd0-07d8-4ba8-9ae5-8e7670c93065?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": [
"L01XE",
"L01XE24"
],
"strength": null,
"pa_number": "EU/1/13/839/003-004",
"substances": [
"Ponatinib hci"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "01/07/2013",
"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 ponatinib.
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.