Ireland· IE-PA-EU/1/18/1291/001-003
Rizmoic 200 microgram Film-coated tablet
A naldemedine product containing naldemedine tosilate, registered in Ireland by Shionogi B.V.. The same ATC class is registered in 14 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Naldemedine is registered in 14 of 19 countries.
Countries holding a registration under ATC A06AH05 (naldemedine), 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
Naldemedine · ATC A06AH05
14 / 19 countries
- Belgiumprice
- Czechiaprice
- Denmark
- Finlandprice
- Franceprice
- Icelandprice
- Ireland
- Italyprice
- Japan
- Netherlands
- Norwayprice
- Polandprice
- United Kingdom
- United Statesprice
Price per daily dose
What a daily dose of naldemedine costs, country by country.
Normalised to the WHO defined daily dose (0.2 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
Naldemedine · price per daily dose (0.2 mg)
USD · FX 28 Sept 2026
- IT Italy$2.82
The record
At a glance
HPRA (Ireland)- Active substance
- Naldemedine tosilate
- Manufacturer
- Shionogi B.V.
- Country
- Ireland (IE)
- ATC code
- A06AH05
- ATC class
- Naldemedine
- Defined daily dose
- 0.2 mg, O
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/18/1291/001-003
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
174 interactions on record for naldemedine.
Graded by severity as the source publishes them — 12 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
Naldemedine · interactions on record
174 records
- 12 severe
- 160 moderate
- 2 minor
Most severe, free to view
- RifampicinJ04AB02severe
- RifapentineJ04AB05severe
- MitotaneL01XX23severe
- EnzalutamideL02BB04severe
- 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
Naldemedine in 13 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaRIZMOICShionogi B.V., Amsterdam
- SpainRIZMOIC 200 MICROGRAMOS COMPRIMIDOS RECUBIERTOS CON PELICULAShionogi B.V.
- FinlandRizmoicShionogi B.V.
- NetherlandsRizmoic 200 microgram, filmomhulde tabletShionogi Limited
- NorwayRizmoicShionogi B.V.
- PolandRizmoicShionogi B.V.
- BelgiumRizmoic 200 µgShionogi Europe
- SwedenRizmoic 200 mikrogram Filmdragerad tablettShionogi B.V
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Rizmoic
- Liechtenstein · Rizmoic
- Norway · Rizmoic
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/59131563-cb0d-43cf-bd94-2aa166d59fd6 GET /v1/drugs/59131563-cb0d-43cf-bd94-2aa166d59fd6?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": [
"A06AH05"
],
"strength": null,
"pa_number": "EU/1/18/1291/001-003",
"substances": [
"Naldemedine tosilate"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "18/02/2019",
"dispensing_status": "Product subject to prescription which may be renewed (B)",
"registration_status": "AU",
"supply_legal_status": "Supply through pharmacies only",
"interchangeable_code": null
}See everything about naldemedine.
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.