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France· FR:61247435

OZAWADE 4,5 mg, comprimés pelliculés

A pitolisant product containing chlorhydrate de pitolisant, registered in France by BIOPROJET, on the national reimbursement list. The same ATC class is registered in 15 of our 19 countries.

Reimbursed in France (Assurance maladie)ATC N07XX11

Checked against Base de données publique des médicaments — BDPM (France) on

Informational only — not a medical device.

SOURCE REGISTER · FRBase de données publique des médicament…normalisedOZAWADE 4,5 mg, comprimés pelliculésATCN07XX11REGISTER NO.FR:61247435PACKS LISTED1CHECKEDSeptember 12, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about chlorhydrate de pitolisantAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

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: France, from Base de données publique des médicaments — BDPM (France)
  • 10 of them publish a price we can compare per daily dose
Search pitolisant products by name

Pitolisant · ATC N07XX11

15 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Icelandprice
  • Ireland
  • Italyprice
  • Netherlands
  • Norwayprice
  • Polandprice
  • Switzerlandprice
  • United Kingdom
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

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.

  • France: $21.04 per daily dose (median across products in the class)
  • Public list prices, converted to USD at the rate date shown
Open the full comparison — free accountDrug prices for market access

Pitolisant · price per daily dose (18 mg)

USD · FX 28 Sept 2026

  • IT Italy$43.24
  • FR France$21.04
Median listed price per WHO defined daily dose, in each market that publishes a price. Open the full comparison

The record

At a glance

Base de données publique des médicaments — BDPM (France)
Active substance
CHLORHYDRATE DE PITOLISANT
Manufacturer
BIOPROJET
Country
France (FR)
ATC code
N07XX11
ATC class
Pitolisant
Defined daily dose
18 mg, O
Reimbursed
Yes
Source register
Base de données publique des médicaments — BDPM (France)
Last checked
September 12, 2026

Packs & prices · 1

1 priced
  • cip13
    3400930232415
    1 flacon(s) polyéthylène haute densité (PEHD) avec fermeture de sécurité enfant de 30 comprimé(s)
    EUR 224.02

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
Check pitolisant against other medicinesHow interaction checks work

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.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

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.

All pitolisant products

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 Base de données publique des médicaments — BDPM (France). 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/03c06e67-13c5-4f34-9030-d1da01cb1090
GET /v1/drugs/03c06e67-13c5-4f34-9030-d1da01cb1090?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.

{
  "cis": "61247435",
  "date_amm": "2021-07-22",
  "type_amm": "Procédure centralisée",
  "numero_ue": "EU/1/21/1546",
  "substance": "CHLORHYDRATE DE PITOLISANT",
  "atc_source": "fr_atc_restore_2026-09-06",
  "statut_amm": "Autorisation active",
  "statut_bdm": null,
  "forme_pharmaceutique": "comprimé pelliculé",
  "voies_administration": "orale",
  "etat_commercialisation": "Commercialisée",
  "surveillance_renforcee": "Non"
}
API referenceMCP serverPlans

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.

Try it freeOpen in the console