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Poland· PL-100342358

Mysimba

A bupropion and naltrexone product containing naltrexoni hydrochloridum + bupropioni hydrochloridum, registered in Poland by Orexigen Therapeutics Ireland Limited. The same ATC class is registered in 12 of our 19 countries.

ATC A08AA62

Checked against URPL (Poland) on

Informational only — not a medical device.

SOURCE REGISTER · PLURPL (Poland)normalisedMysimbaATCA08AA62REGISTER NO.PL-100342358PACKS LISTED6CHECKEDSeptember 27, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about naltrexoni hydrochloridum + bupropioni hydrochloridumAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

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: Poland, from URPL (Poland)
  • 7 of them publish a price we can compare per daily dose
Search bupropion and naltrexone products by name

Bupropion and naltrexone · ATC A08AA62

12 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Netherlands
  • Norwayprice
  • Polandprice
  • United Kingdom
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

URPL (Poland)
Active substance
Naltrexoni hydrochloridum + Bupropioni hydrochloridum
Manufacturer
Orexigen Therapeutics Ireland Limited
Country
Poland (PL)
ATC code
A08AA62
ATC class
Bupropion and naltrexone
Defined daily dose
4 DE, O
Reimbursed
Not published by this register
Source register
URPL (Poland)
Last checked
September 27, 2026

Packs & prices · 6

  • gtin
    05903792743504
  • gtin
    05909991585433
  • gtin
    05909991272210
  • gtin
    05909991426422
  • gtin
    05901878600703
  • gtin
    05905591994125

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.

All bupropion and naltrexone products

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 URPL (Poland). 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/c862a497-1197-4af6-ac40-26ebaae8f650
GET /v1/drugs/c862a497-1197-4af6-ac40-26ebaae8f650?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": "Tabletki o przedłużonym uwalnianiu",
  "source": "urpl",
  "strength": "8 mg + 90 mg",
  "packaging": "05909991272210 ¦ Rp ¦ EU/1/14/988/001 ¦ 107987\n112 tabl.\n05909991426422 ¦ Rp ¦ EU/1/14/988/002 ¦ 125899\n28 tabl.\n05901878600703 ¦ Rp ¦ EU/1/14/988/001 ¦ Delfarma Sp. z o.o. ¦ 134423\n112 tabl.\n05903792743504 ¦ Rp ¦ EU/1/14/988/001 ¦ InPharm Sp. z o.o. ¦ 137189\n112 tabl.\n05909991585433 ¦ Rp ¦ EU/1/14/988/001 ¦ Medezin Sp. z o.o. ¦ 163954\n112 tabl.\n05905591994125 ¦ Rp ¦ EU/1/14/988/001 ¦ Allpharm Sp. z o.o. sp.k. ¦ 167231\n112 tabl.",
  "substance": "Naltrexoni hydrochloridum 8 mg + Bupropioni hydrochloridum 90 mg",
  "common_name": "Naltrexoni hydrochloridum + Bupropioni hydrochloridum",
  "pl_product_id": "100342358",
  "pozwolenie_nr": null,
  "auth_procedure": "CEN",
  "authorisation_validity": null
}
API referenceMCP serverPlans

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.

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