Sweden· SE-20231208000019
Otezla 20 mg Filmdragerad tablett
A medicinal product containing apremilast, registered in Sweden by Amgen Europe B.V..
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
- Apremilast
- Manufacturer
- Amgen Europe B.V.
- 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_varunummer20231208000019
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Apremilast in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaAPREMILAST ACCORDAccord Healthcare S.L.U., Barcelona
- United StatesOtezlaAmgen, Inc
- IcelandApremilast AccordAccord Healthcare S.L.U.
- BelgiumApremilast Accord 20 mgAccord Healthcare
- NetherlandsApremilast Accord 20 mg filmomhulde tablettenAccord Healthcare S.L.U.
- NorwayApremilast AccordAccord Healthcare S.L.
- IrelandApremilast Accord 20 mg film-coated tabletsAccord Healthcare S.L.U.
- FranceOTEZLA 20 mg, comprimé pelliculéAMGEN EUROPE
Authorised across Europe · EMA
The same active substance is authorised in 30 EEA countries. Names it is sold under:
- Austria · Apremilast +pharma, Apremilast Devatis
- Belgium · Apremilast Eg, Apremilast Hcs
- Bulgaria · Тивлемак
- Cyprus · Apremilast Ebewe, Apremilast Sandoz
- Czechia · Apremilast +pharma, Apremilast Belupo
- Germany · Apremilast, Apremilast 089pharm
- Denmark · Apremilast Devatis, Apremilast Stada
- Estonia · Apremilast Krka, Apremilast Stada
- Spain · Apremilast, Apremilast Aurovitas Spain
- Finland · Apremilast Avansor, Apremilast Bioglan
- France · Apremilast Arrow, Apremilast Biogaran
- United Kingdom (Northern Ireland) · Apremilast, Apremilast Amarox
- Greece · Afimax, Apremilast Anabiosis
- Croatia · Aperzyx, Apremilast Belupo
- Hungary · Apremilast Kezdőcsomag Stada, Apremilast Krka
- Ireland · Apremilast 30mg Tablets, Apremilast Aurobindo
- Iceland · Apremilast Accord, Apremilast Aristo
- Italy · Apremilast Day Zero, Apremilast Dr. Reddy’s
- Liechtenstein · Apremilast Accord
- Lithuania · Apremilast Krka, Apremilast Stada
- Luxembourg · Apremilast Eg
- Latvia · Apremilast Krka, Apremilast Stada
- Malta · Apremilast, Apremilast Clonmel
- Netherlands · Apremilast Amarox, Apremilast Devatis
- Norway · Apremilast Accord, Apremilast Devatis
- Poland · Apremilast Aristo, Apremilast Farmaprojects
- Portugal · Apremilaste Humanis
- Romania · Apremilast Stada
- Slovenia · Apremilast Belupo, Apremilast Elpen
- Slovakia · Apremilast Belupo, Apremilast Hcs
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/7c3d6679-eb76-4f7b-84a9-73a244eb6ef8 GET /v1/drugs/7c3d6679-eb76-4f7b-84a9-73a244eb6ef8?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": "20231208000019",
"product_page": "https://www.lakemedelsverket.se/sv/sok-lakemedelsfakta/lakemedel?id=20231208000019",
"product_doc_link": "https://www.ema.europa.eu/sv/documents/product-information/otezla-epar-product-information_sv.pdf"
}See everything about apremilast.
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.