Finland· FI-REL-REL55729
Mysimba
A bupropion and naltrexone product containing naltrexoni hydrochloride + bupropion hydrochloride, registered in Finland by Orifarm Oy. 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
- Orifarm Oy
- 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 · 0
No packs listed by the register for this record.
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
- NorwayMysimbaOrexigen Therapeutics Ireland Limited (1)
- 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/d993a31d-634f-4afa-a0a1-dfd86a15f4d6 GET /v1/drugs/d993a31d-634f-4afa-a0a1-dfd86a15f4d6?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",
"fimea_rel_id": "REL55729",
"authorised_at": "2019-11-12"
}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.