Sweden· SE-20191110000012
Ozawade 4,5 mg Filmdragerad tablett
A medicinal product containing pitolisant, registered in Sweden by Bioprojet Pharma.
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
- Pitolisant
- Manufacturer
- Bioprojet Pharma
- 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_varunummer20191110000012
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Pitolisant in 15 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaOZAWADEBioprojet Pharma, Paříž
- BelgiumOzawade 4.5 mgBioprojet Pharma
- NorwayWakixAbacus Medicine A/S
- PolandOzawadeBioprojet Pharma
- SpainOZAWADE 4,5 MG COMPRIMIDOS RECUBIERTOS CON PELICULABioprojet Pharma
- FinlandOzawadeBioprojet Pharma
- FranceOZAWADE 4,5 mg, comprimés pelliculésBIOPROJET
- IrelandOzawade 4.5 mg film-coated tabletsBioprojet Pharma
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Ozawade, Wakix
- Liechtenstein · Ozawade, Wakix
- Norway · Ozawade, Wakix
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/bc32c56b-a8ae-487e-9aa2-851a598ef28c GET /v1/drugs/bc32c56b-a8ae-487e-9aa2-851a598ef28c?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": [
"EMA",
"EPAR"
],
"se_npl_id": "20191110000012",
"product_page": "https://www.lakemedelsverket.se/sv/sok-lakemedelsfakta/lakemedel?id=20191110000012",
"product_doc_link": "https://www.ema.europa.eu/en/medicines/human/EPAR/ozawade"
}See everything about pitolisant.
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.