Ireland· IE-PA-PA2165/023/002
Hydromorphone hydrochloride 50 mg/ml solution for injection/infusion
A hydromorphone product containing hydromorphone hydrochloride, registered in Ireland by AS Kalceks. The same ATC class is registered in 15 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Hydromorphone is registered in 15 of 19 countries.
Countries holding a registration under ATC N02AA03 (hydromorphone), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 7 of them publish a price we can compare per daily dose
Hydromorphone · ATC N02AA03
15 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Franceprice
- Germany
- Ireland
- Japan
- Netherlands
- Norwayprice
- Sweden
- Switzerlandprice
- United Kingdom
- United Statesprice
Price per daily dose
What a daily dose of hydromorphone costs, country by country.
Normalised to the WHO defined daily dose (20 mg), so markets compare like for like.
- 1 market with a comparable price for this class
- Public list prices, converted to USD at the rate date shown
Hydromorphone · price per daily dose (20 mg)
USD · FX 28 Sept 2026
- CH Switzerland$4.48
The record
At a glance
HPRA (Ireland)- Active substance
- Hydromorphone hydrochloride
- Manufacturer
- AS Kalceks
- Country
- Ireland (IE)
- ATC code
- N02AA03
- ATC class
- Hydromorphone
- Defined daily dose
- 20 mg, O
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberPA2165/023/002
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
281 interactions on record for hydromorphone.
Graded by severity as the source publishes them — 18 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
Hydromorphone · interactions on record
281 records
- 18 severe
- 98 moderate
- 160 info
Most severe, free to view
- AlvimopanA06AH02severe
- EthanolB05XX04severe
- ChlorphenesinD01AE07severe
- ChlorphenesinG01AX21severe
5 more interactions with mechanism and management, from a commercially licensed source.
Sign in to check- 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
Hydromorphone in 14 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- SwedenGerodolan 50 mg/ml Injektions-/infusionsvätska, lösningG.L. Pharma GmbH
- NorwayHydofonG.L. Pharma Gmbh
- BelgiumPalladone 50 mg/mlMundipharma
- United StatesDilaudidFresenius Kabi USA, LLC
- GermanyDolomorphonG.L. Pharma Gmbh
- SwitzerlandHydromorphone Mundipharma 1.3 mg, KapselnMundipharma Regulatory GmbH
- CzechiaPALLADONE SRMundipharma Gesellschaft m.b.H., Vídeň
- CanadaAPO-HYDROMORPHONEAPOTEX INC
Authorised across Europe · EMA
The same active substance is authorised in 19 EEA countries. Names it is sold under:
- Austria · Hydagelan, Hydal
- Belgium · Palladone
- Czechia · Palladone
- Germany · Dolomorphon, Dolomorphon Akut
- Denmark · Hydromorphonhydrochlorid Kalceks, Palladon
- Estonia · Hydromorphone Kalceks
- Spain · Edunix
- Finland · Hydofon, Hydromorphone Kalceks
- France · Hydagelan Lp, Sophidone L.P
- United Kingdom (Northern Ireland) · Palladone, Palladone-Sr
- Italy · Medepidol, Tiblelan
- Liechtenstein · Jurnista
- Luxembourg · Hydromorphon Hameln, Palladone
- Malta · Hydromorphone Aristo, Hydromorphone Quintian
- Netherlands · Hydagelan, Hydromorfonhydrochloride Kalceks
- Norway · Hydofon, Hydromorfonhydroklorid Kalceks
- Portugal · Edunix, Hidromorfona Aristo
- Sweden · Gerodolan, Hydofon
- Slovakia · Palladone-Sr Capsules
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/96d9add4-ad67-4223-bd74-3b9c6be3a717 GET /v1/drugs/96d9add4-ad67-4223-bd74-3b9c6be3a717?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": "Solution for injection/infusion",
"routes": [
"Intravenous use",
"Subcutaneous use"
],
"source": "hpra",
"atc_all": [
"N02AA03"
],
"strength": null,
"pa_number": "PA2165/023/002",
"substances": [
"Hydromorphone hydrochloride"
],
"legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)",
"market_info": "Not marketed",
"authorised_at": "14/04/2022",
"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 hydromorphone.
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.