Sweden· SE-20170922000014
Otazem 250 mikrogram/ml Örondroppar, lösning i endosbehållare
A medicinal product containing fluocinolone acetonide, registered in Sweden by POA Pharma Scandinavia AB.
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
- Fluocinolone Acetonide
- Manufacturer
- POA Pharma Scandinavia AB
- 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_varunummer20170922000014
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Fluocinolone acetonide in 13 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- FinlandOtazemPOA Pharma Scandinavia AB
- NorwayOtazemPOA Pharma Scandinavia AB
- United StatesDerma-Smoothe/FSRoyal Pharmaceuticals, LLC
- PolandFlucinarInPharm Sp. z o.o.
- United KingdomILUVIEN 190microgram intravitreal implant in applicatorAlimera Sciences Ltd
- GermanyFlucinarAbanta Pharma Gmbh
- Japanフルオシノロンアセトニド陽進堂ホールディングス
- CzechiaFLUCINARBausch Health Ireland Limited, Dublin
Authorised across Europe · EMA
The same active substance is authorised in 23 EEA countries. Names it is sold under:
- Austria · Iluvien
- Belgium · Iluvien
- Bulgaria · Абрикорт, Флуцинар
- Czechia · Flucinar, Iluvien
- Germany · Flucinar, Iluvien
- Denmark · Iluvien, Otazem
- Spain · Ekzem, Fluocid Forte
- Finland · Iluvien, Otazem
- France · Iluvien
- United Kingdom (Northern Ireland) · Iluvien, Synalar
- Greece · Synalar Simple
- Hungary · Flucinar
- Ireland · Iluvien
- Italy · Ekzem, Fluovitef
- Lithuania · Flucinar
- Luxembourg · Iluvien
- Latvia · Flucinar
- Netherlands · Iluvien
- Norway · Iluvien, Otazem
- Poland · Flucinar, Iluvien
- Portugal · Ekzem, Iluvien
- Romania · Fluocinolon Acetonid Laropharm
- Slovakia · Flucinar
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/1759b2d0-1dba-4900-ab07-4bd5be41ef35 GET /v1/drugs/1759b2d0-1dba-4900-ab07-4bd5be41ef35?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": [
"PL",
"SmPC"
],
"se_npl_id": "20170922000014",
"product_page": "https://www.lakemedelsverket.se/sv/sok-lakemedelsfakta/lakemedel?id=20170922000014",
"product_doc_link": "https://docetp.mpa.se/LMF/Otazem%20ear%20drops%20solution%20in%20single-dose%20container%20SmPC_09001bee807a60ac.pdf"
}See everything about fluocinolone acetonide.
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.