Sweden· SE-20220530000057
Orkambi 75 mg/94 mg Granulat i dospåse
A medicinal product containing lumacaftor + ivacaftor, registered in Sweden by Vertex Pharmaceuticals Ireland Ltd.
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
- Lumacaftor + Ivacaftor
- Manufacturer
- Vertex Pharmaceuticals Ireland Ltd
- 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_varunummer20220530000057
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Lumacaftor + ivacaftor in 13 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United StatesORKAMBIVertex Pharmaceuticals Incorporated
- SwitzerlandOrkambi 100 mg / 125 mg, FilmtablettenVertex Pharmaceuticals (CH) GmbH
- CzechiaORKAMBIVertex Pharmaceuticals (Ireland) Limited, Dublin
- SpainORKAMBI 100 MG/125 MG COMPRIMIDOS RECUBIERTOS CON PELICULAVertex Pharmaceuticals (Ireland) Limited
- FinlandOrkambiVertex Pharmaceuticals (Ireland) Limited
- FranceORKAMBI 100 mg/125 mg, comprimé pelliculéVERTEX PHARMACEUTICALS (IRELAND)
- United KingdomOrkambi 100mg/125mg granules sachetsVertex Pharmaceuticals (Europe) Ltd
- IrelandOrkambi 100 mg/125 mg film-coated tabletsVertex Pharmaceuticals (Ireland) Limited
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Orkambi
- Liechtenstein · Orkambi
- Norway · Orkambi
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/e8fc1aa9-0c30-4c5c-88b0-4ad57181f48c GET /v1/drugs/e8fc1aa9-0c30-4c5c-88b0-4ad57181f48c?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": [
"EPAR",
"Dispensbeslut",
"EMA"
],
"se_npl_id": "20220530000057",
"product_page": "https://www.lakemedelsverket.se/sv/sok-lakemedelsfakta/lakemedel?id=20220530000057",
"product_doc_link": "https://www.ema.europa.eu/sv/documents/product-information/orkambi-epar-product-information_sv.pdf"
}See everything about lumacaftor + ivacaftor.
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.