Czechia· CZ-0255188
OZAWADE
A pitolisant product containing pitolisant hydrochloride, registered in Czechia by Bioprojet Pharma, Paříž. The same ATC class is registered in 15 of our 19 countries.
Checked against SÚKL (Czech Republic) on
Informational only — not a medical device.
Where it is registered
Pitolisant is registered in 15 of 19 countries.
Countries holding a registration under ATC N07XX11 (pitolisant), each read from that country’s own register.
- This record: Czechia, from SÚKL (Czech Republic)
- 10 of them publish a price we can compare per daily dose
Pitolisant · ATC N07XX11
15 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Franceprice
- Icelandprice
- Ireland
- Italyprice
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
- United Kingdom
- United Statesprice
Price per daily dose
What a daily dose of pitolisant costs, country by country.
Normalised to the WHO defined daily dose (18 mg), the median price runs from $21.04 in France to $43.24 in Italy — a ×2.1 gap.
- 2 markets with a comparable price for this class
- Public list prices, converted to USD at the rate date shown
Pitolisant · price per daily dose (18 mg)
USD · FX 28 Sept 2026
- IT Italy$43.24
- FR France$21.04
The record
At a glance
SÚKL (Czech Republic)- Active substance
- PITOLISANT HYDROCHLORIDE
- Manufacturer
- Bioprojet Pharma, Paříž
- Country
- Czechia (CZ)
- ATC code
- N07XX11
- ATC class
- Pitolisant
- Defined daily dose
- 18 mg, O
- Reimbursed
- Not published by this register
- Source register
- SÚKL (Czech Republic)
- Last checked
- September 28, 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.
Interactions
272 interactions on record for pitolisant.
Graded by severity as the source publishes them — 49 severe. Severity grades are free for everyone; mechanism and management come with Growth.
- Severity for every pair — free, no plan needed
- The source, licence and sync date on every record
- Mechanism and what to do for each pair — Growth plan
Pitolisant · interactions on record
272 records
- 49 severe
- 221 moderate
- 2 minor
Most severe, free to view
- PapaverineA03AD01severe
- CisaprideA03FA02severe
- DolasetronA04AA04severe
- PapaverinC04AX38severe
- Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
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.
- SwedenOzawade 18 mg Filmdragerad tablettBioprojet Pharma
- BelgiumOzawade 18 mgBioprojet Pharma
- SpainOZAWADE 18 MG COMPRIMIDOS RECUBIERTOS CON PELICULABioprojet Pharma
- FinlandOzawadeBioprojet Pharma
- FranceOZAWADE 18 mg, comprimés pelliculésBIOPROJET
- IrelandOzawade 18 mg film-coated tabletsBioprojet Pharma
- IcelandOzawadeBioprojet Pharma
- NetherlandsOzawade 18 mg filmomhulde tablettenBioprojet 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 SÚKL (Czech Republic). 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/651af3b4-890a-457e-bcb9-83ea4c85a37a GET /v1/drugs/651af3b4-890a-457e-bcb9-83ea4c85a37a?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.
{
"form": "TBL FLM",
"source": "sukl",
"strength": "18MG",
"pack_size": "90",
"substance": "PITOLISANT HYDROCHLORIDE",
"cz_kod_sukl": "0255188",
"product_type": "CH",
"substance_codes": "20935",
"registration_state": "R",
"registration_number": "EU/1/21/1546/003"
}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.