Pitolisant

Wakix 4,5 MG Comprimidos Recubiertos con Pelicula

4.45 mg comprimido recubierto con películaSpainMarketedAuthorised 3 Sept 2016

Product informationAsk Osler about it

In other countries

The same active substances on other registers, the same brand first.

Authorised centrally in the EU

This national listing belongs to a medicine the European Commission authorised for the whole EU.

WakixEuropean UnionAuthorised

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

Discover Osler

Pitolisant

Wakix 4,5 MG Comprimidos Recubiertos con Pelicula

4.45 mg comprimido recubierto con películaSpainMarketedAuthorised 3 Sept 2016

Product informationAsk Osler about it

In other countries

The same active substances on other registers, the same brand first.

Authorised centrally in the EU

This national listing belongs to a medicine the European Commission authorised for the whole EU.

WakixEuropean UnionAuthorised

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

Discover Osler

Wakix 4,5 mg filmomhulde tablettenNetherlands · Filmomhulde tablet · Bioprojet Pharma

WAKIX 4,5 mgRomania · 4,5 mg · compr. film. · Bioprojet Pharma

WakixUnited States · 17.8MG BASE, 4.45MG BASE · tablet · Harmony

OzawadeItaly · Compressa rivestita con film · Bioprojet Pharma

Ozawade 18 mg filmomhulde tablettenNetherlands · Filmomhulde tablet · Bioprojet Pharma

PitolisantUnited States · 4.45MG · tablet · MSN Laboratories Private LTD

PitolisantUnited States · 17.8MG · tablet · Novitium Pharma LLC

OzawadeEuropean Union · Bioprojet Pharma

OzawadeCroatia

Packs

Pack	Code	Status
WAKIX 4,5 MG COMPRIMIDOS RECUBIERTOS CON PELICULA, 30 comprimidos	712339

Documents

The official texts, at the regulator.

Sources and licences

Compiled by Prognia from the public register below; the register’s text is the official one.

Agencia Española de Medicamentos y Productos Sanitarios

Fuente de la información: Agencia Española de Medicamentos y Productos Sanitarios www.aemps.gob.es; CIMA medicamentos, acquired 11 October 2026 UTC; each source response/update date retained.

Licence: AEMPS explicit public open-data reuse for citizens and companies; source attribution and update date required · Added 12 Oct 2026

Report an error or request removalCorrections from the holder or the register are welcome.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Active substance: Pitolisant
Strength: 4.45 mg
Dosage form: comprimido recubierto con película
Route: vía oral
Register: Spain (AEMPS)
Status: Marketed
Status in the register: Autorizado, comercializado
Authorised: 3 Sept 2016
Registration: 1151068001
Marketing authorisation holder: Bioprojet Pharma
Procedure: EU centralised
Supply: Diagnóstico Hospitalario
EU number: EU/1/15/1068

Spain

Ozawade 4,5 MG Comprimidos Recubiertos con PeliculaPitolisant · 5 mg · comprimido recubierto con películaSpain