Finland· FI-REL-REL44462
Mysimba
A bupropion and naltrexone product containing naltrexoni hydrochloride + bupropion hydrochloride, registered in Finland by Orexigen Therapeutics Ireland Limited. The same ATC class is registered in 12 of our 19 countries.
Checked against Fimea (Finland) 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: Finland, from Fimea (Finland)
- 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
Fimea (Finland)- Active substance
- Naltrexoni hydrochloride + Bupropion hydrochloride
- Manufacturer
- Orexigen Therapeutics Ireland Limited
- Country
- Finland (FI)
- ATC code
- A08AA62
- ATC class
- Bupropion and naltrexone
- Defined daily dose
- 4 DE, O
- Reimbursed
- Not published by this register
- Source register
- Fimea (Finland)
- Last checked
- September 27, 2026
Packs & prices · 1
1 priced- fi_myyntilupa190131112EUR 105.46
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.
- CzechiaMYSIMBAOrexigen Therapeutics Ireland Limited, Dublin
- NorwayMysimba2care4 ApS
- IrelandMysimba 8 mg/90 mg prolonged-release tabletsOrexigen Therapeutics Ireland Limited
- 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 Fimea (Finland). 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/ae28d1d7-4227-404b-8b97-5c62a7c76a88 GET /v1/drugs/ae28d1d7-4227-404b-8b97-5c62a7c76a88?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.
{
"ddd": "4",
"form": "depottabletti",
"route": "Suun kautta",
"ddd_unit": "ED",
"strength": "8 mg / 90 mg",
"atc_label": "bupropioni ja naltreksoni",
"ma_number": null,
"auth_status": "Myyntilupa myönnetty",
"eu_ma_number": "EU/1/14/988/001-002",
"fimea_rel_id": "REL44462",
"authorised_at": "2015-03-26"
}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.