Ireland· IE-PA-EU/1/14/988/001-002
Mysimba 8 mg/90 mg prolonged-release tablets
A bupropion and naltrexone product containing naltrexone hydrochloride + bupropion hydrochloride, registered in Ireland by Orexigen Therapeutics Ireland Limited. The same ATC class is registered in 12 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Bupropion and naltrexone is registered in 12 of 19 countries.
Countries holding a registration under ATC A08AA62 (bupropion and naltrexone), 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
Bupropion and naltrexone · ATC A08AA62
12 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
- United Kingdom
- United Statesprice
The record
At a glance
HPRA (Ireland)- Active substance
- Naltrexone hydrochloride + Bupropion hydrochloride
- Manufacturer
- Orexigen Therapeutics Ireland Limited
- Country
- Ireland (IE)
- ATC code
- A08AA62
- ATC class
- Bupropion and naltrexone
- Defined daily dose
- 4 DE, O
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/14/988/001-002
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Bupropion and naltrexone in 11 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- FinlandMysimbaOrifarm Oy
- CzechiaMYSIMBAOrexigen Therapeutics Ireland Limited, Dublin
- NorwayMysimbaOrexigen Therapeutics Ireland Limited (1)
- IcelandMysimbaOrexigen Therapeutics Ireland Limited
- NetherlandsMysimba 8 mg/90 mg tabletten met verlengde afgifteOrexigen Therapeutics Ireland Limited
- PolandMysimbaOrexigen Therapeutics Ireland Limited
- SwedenMysimba 8 mg/90 mg DepottablettOrexigen Therapeutics Ireland Limited
- CanadaCONTRAVEBAUSCH HEALTH, CANADA INC.
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Mysimba
- Liechtenstein · Mysimba
- Norway · Mysimba
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/35b1647d-4e13-42e9-a395-458760a9d3d9 GET /v1/drugs/35b1647d-4e13-42e9-a395-458760a9d3d9?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": "Prolonged-release tablet",
"routes": [
"Oral use"
],
"source": "hpra",
"atc_all": [
"A08AA",
"A08AA62"
],
"strength": null,
"pa_number": "EU/1/14/988/001-002",
"substances": [
"Naltrexone hydrochloride",
"Bupropion hydrochloride"
],
"legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": null,
"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 bupropion and naltrexone.
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.