Ireland· IE-PA-EU/1/14/969/001
SCENESSE 16 mg implant
A afamelanotide product containing afamelanotide, registered in Ireland by Clinuvel Europe Limited. The same ATC class is registered in 10 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Afamelanotide is registered in 10 of 19 countries.
Countries holding a registration under ATC D02BB02 (afamelanotide), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 6 of them publish a price we can compare per daily dose
Afamelanotide · ATC D02BB02
10 / 19 countries
- Belgiumprice
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Netherlands
- Polandprice
- United Kingdom
- United Statesprice
The record
At a glance
HPRA (Ireland)- Active substance
- Afamelanotide
- Manufacturer
- Clinuvel Europe Limited
- Country
- Ireland (IE)
- ATC code
- D02BB02
- ATC class
- Afamelanotide
- Defined daily dose
- 0.00822 DE, Implantat
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/14/969/001
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Afamelanotide in 10 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United KingdomScenesse 16mg implantClinuvel (UK) Ltd
- NetherlandsSCENESSE 16 mg, implantaatClinuvel Europe Limited
- BelgiumScenesse 16 mgClinuvel Europe
- CzechiaSCENESSECLINUVEL EUROPE LIMITED, Dublin
- SpainSCENESSE 16 MG IMPLANTEClinuvel (Uk) Limited
- FinlandScenesseClinuvel Europe Limited
- IcelandSCENESSEClinuvel Europe Limited
- PolandScenesseCLINUVEL EUROPE LIMITED
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Scenesse
- Liechtenstein · Scenesse
- Norway · Scenesse
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/b4d13940-a811-4840-a2f9-ca8309b3f10e GET /v1/drugs/b4d13940-a811-4840-a2f9-ca8309b3f10e?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": "Implant",
"routes": [
"Subcutaneous use"
],
"source": "hpra",
"atc_all": [
"D02BB",
"D02BB02"
],
"strength": null,
"pa_number": "EU/1/14/969/001",
"substances": [
"Afamelanotide"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "22/12/2014",
"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 afamelanotide.
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.