Sweden· SE-20131031000012
Mysimba 8 mg/90 mg Depottablett
A medicinal product containing bupropion hydrochloride + naltrexone hydrochloride, registered in Sweden by Orexigen Therapeutics Ireland Limited.
Checked against Swedish Medical Products Agency (Sweden) on
Informational only — not a medical device.
The record
At a glance
Swedish Medical Products Agency (Sweden)- Active substance
- Bupropion Hydrochloride + Naltrexone Hydrochloride
- Manufacturer
- Orexigen Therapeutics Ireland Limited
- Country
- Sweden (SE)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- Swedish Medical Products Agency (Sweden)
- Last checked
- October 1, 2026
Packs & prices · 1
- se_varunummer20131031000012
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Bupropion hydrochloride + naltrexone hydrochloride in 11 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- FinlandMysimbaOrifarm Oy
- NorwayMysimba2care4 ApS
- CzechiaMYSIMBAOrexigen Therapeutics Ireland Limited, Dublin
- 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
- 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 Swedish Medical Products Agency (Sweden). 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/1cbc92d1-81ce-4a39-9e6a-46216fa39ee8 GET /v1/drugs/1cbc92d1-81ce-4a39-9e6a-46216fa39ee8?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.
{
"source": "lakemedelsverket",
"doc_types": [
"EMA",
"DHPC",
"EPAR"
],
"se_npl_id": "20131031000012",
"product_page": "https://www.lakemedelsverket.se/sv/sok-lakemedelsfakta/lakemedel?id=20131031000012",
"product_doc_link": "https://www.ema.europa.eu/en/medicines/human/EPAR/mysimba"
}See everything about bupropion hydrochloride + naltrexone hydrochloride.
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.