Spain· ES:114988001
MYSIMBA 8 MG/90 MG COMPRIMIDOS DE LIBERACION PROLONGADA
A medicinal product containing naltrexona + bupropion, registered in Spain by Orexigen Therapeutics Ireland Limited.
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- naltrexona + bupropion
- Manufacturer
- Orexigen Therapeutics Ireland Limited
- Country
- Spain (ES)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- AEMPS CIMA (Spain)
- Last checked
- September 12, 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
Naltrexona + bupropion in 11 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- FinlandMysimbaParanova Oy
- CzechiaMYSIMBAOrexigen Therapeutics Ireland Limited, Dublin
- NorwayMysimba2care4 ApS
- 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 AEMPS CIMA (Spain). 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/ab7de90e-4b91-4fc6-8661-7d31a18b8ca7 GET /v1/drugs/ab7de90e-4b91-4fc6-8661-7d31a18b8ca7?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.
{
"cpresc": "Medicamento Sujeto A Prescripción Médica",
"estado": "{\"aut\":1476114928000}",
"nregistro": "114988001",
"substance": "naltrexona + bupropion"
}See everything about naltrexona + bupropion.
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.