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Structural formula: Pitolisant hydrochlorideStructural formula: Pitolisant hydrochloride

OZAWADE 18 mg, film-coated tablet 30 tablets

Active ingredients: Pitolisant hydrochloride, Pitolisant

Commercialized according to BDPMDispensing in France: Prescription only
Film-coated tablet30 tabletsorale

No current ANSM shortage notice is included

Package details

Original BDPM fields are shown in French.

Official name
OZAWADE 18 mg, comprimé pelliculé
Pharmaceutical form
comprimé pelliculé
Route of administration
orale
Presentation description
1 flacon(s) polyéthylène haute densité (PEHD) avec fermeture de sécurité enfant de 30 comprimé(s)
Marketing authorisation holder
BIOPROJET PHARMA (FRANCE)
Reimbursement according to BDPM
65 %
Approval for use in healthcare institutions
oui
Commercialization declaration date
24 Jun 2022
Prescription and dispensing conditions
Prescription only
  • List I: prescription-only medicine
  • Initial prescription by a hospital doctor
  • Prescribed by specialists only
Original BDPM wording: liste I · prescription initiale hospitalière annuelle · prescription réservée aux médecins exerçant dans les centres du sommeil · prescription réservée aux spécialistes et services PNEUMOLOGIE · prescription réservée aux titulaires de la Formation Spécialisée Transversale Sommeil · renouvellement non restreint
Enhanced ANSM monitoring
No

BDPM identifiers

CIS60227166CIP73023242CIP133400930232422

Composition in BDPM

Composition in BDPM
ComponentAmount per unitSource type
PITOLISANTcomprimé17,8 mg · un compriméFT
CHLORHYDRATE DE PITOLISANTcomprimé—SA

Information is based on BDPM data and is for reference only. Consult a doctor before use.

Similar medicines

Similar medicines are listed using the official BDPM catalog. Availability must be checked separately. Consult a doctor or pharmacist before switching medicines.

The current BDPM data does not list similar medicines for this product.