Spain· ES:1211546002
OZAWADE 18 MG COMPRIMIDOS RECUBIERTOS CON PELICULA
A medicinal product containing pitolisant, registered in Spain by Bioprojet Pharma.
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- pitolisant
- Manufacturer
- Bioprojet Pharma
- Country
- Spain (ES)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- AEMPS CIMA (Spain)
- Last checked
- June 3, 2026
Packs & prices · 0
No packs listed by the register for this record.
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
- SwedenOzawade 18 mg Filmdragerad tablettBioprojet Pharma
- PolandOzawadeBioprojet Pharma
- BelgiumOzawade 18 mgBioprojet Pharma
- FinlandOzawadeBioprojet Pharma
- FranceOZAWADE 18 mg, comprimés pelliculésBIOPROJET
- IrelandOzawade 18 mg film-coated tabletsBioprojet Pharma
- IcelandOzawadeBioprojet 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 AEMPS CIMA (Spain). 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/b8127535-5052-475f-9258-ed8950d59ca7 GET /v1/drugs/b8127535-5052-475f-9258-ed8950d59ca7?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.
{
"cpresc": "Diagnóstico Hospitalario",
"estado": "{\"aut\":1636651701000}",
"nregistro": "1211546002",
"substance": "pitolisant"
}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.