Drug Database
Back to search

Belgium· BE-AMP-SAM591280-00

Ozawade 4.5 mg

A pitolisant product containing pitolisant hydrochloride, registered in Belgium by Bioprojet Pharma. The same ATC class is registered in 15 of our 19 countries.

ATC N07XX11

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedOzawade 4.5 mgATCN07XX11REGISTER NO.BE-AMP-SAM591280-00PACKS LISTED2CHECKEDSeptember 26, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about pitolisant hydrochlorideAnswers 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: Belgium, from FAMHP / AFMPS (Belgium)
  • 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.

  • 2 markets with a comparable price for this 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

FAMHP / AFMPS (Belgium)
Active substance
Pitolisant Hydrochloride
Manufacturer
Bioprojet Pharma
Country
Belgium (BE)
ATC code
N07XX11
ATC class
Pitolisant
Defined daily dose
18 mg, O
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 2

1 priced
  • be_apb
    4640595
    EUR 221.11
  • be_apb
    7749906

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 FAMHP / AFMPS (Belgium). 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/5cd86875-ff5f-4ea8-891e-6b14caa3633a
GET /v1/drugs/5cd86875-ff5f-4ea8-891e-6b14caa3633a?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": "Film-coated tablet",
  "source": "afmps",
  "status": "AUTHORIZED",
  "name_en": "Ozawade 4.5 mg",
  "name_fr": "Ozawade 4.5 mg",
  "name_nl": "Ozawade 4.5 mg",
  "amp_code": "SAM591280-00",
  "strengths": [
    "4.4500",
    "4.4500",
    "4.4500"
  ],
  "pack_count": 4,
  "substances": [
    "Pitolisant Hydrochloride",
    "Pitolisant"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Pitolisant",
  "authorisation_numbers": [
    "EU/1/21/1546/001",
    "EU/1/21/1546/004",
    "EU/1/21/1546/006",
    "EU/1/21/1546/005"
  ]
}
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