Ireland· IE-PA-EU/1/18/1276/001-002
Myalepta 11.3 mg powder for solution for injection
A amino acids and derivatives product containing metreleptin, registered in Ireland by Chiesi Farmaceutici S.p.A.. The same ATC class is registered in 3 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Metreleptin is registered in 3 of 19 countries.
Countries holding a registration under ATC A16AA (amino acids and derivatives), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 2 of them publish a price we can compare per daily dose
Metreleptin · ATC A16AA
3 / 19 countries
- Ireland
- Norwayprice
- United Statesprice
The record
At a glance
HPRA (Ireland)- Active substance
- Metreleptin
- Manufacturer
- Chiesi Farmaceutici S.p.A.
- Country
- Ireland (IE)
- ATC code
- A16AA
- ATC class
- Amino acids and derivatives
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/18/1276/001-002
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Metreleptin in 14 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- FranceMYALEPTA 11,3 mg, poudre pour solution injectableCHIESI FARMACEUTICI
- NetherlandsMyalepta 11.3 mg poeder voor oplossing voor injectieChiesi Farmaceutici S.p.A.
- CzechiaMYALEPTAChiesi Farmaceutici S.p.A., Parma
- CanadaMYALEPTACHIESI FARMACEUTICI S.P.A.
- SpainMYALEPTA 11,3 MG POLVO PARA SOLUCION INYECTABLEChiesi Farmaceutici S.P.A.
- FinlandMyaleptaChiesi Farmaceutici S.p.A.
- United KingdomMyalepta 11.3mg powder for solution for injection vialsChiesi Ltd
- IcelandMyaleptaChiesi Farmaceutici S.p.A.*
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Myalepta
- Liechtenstein · Myalepta
- Norway · Myalepta
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/02834161-e154-4f25-9b75-547150f43458 GET /v1/drugs/02834161-e154-4f25-9b75-547150f43458?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": "Powder for solution for injection",
"routes": [
"Subcutaneous use"
],
"source": "hpra",
"atc_all": [
"A16AA"
],
"strength": null,
"pa_number": "EU/1/18/1276/001-002",
"substances": [
"Metreleptin"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "30/07/2018",
"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 metreleptin.
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.