In other countries
The same active substances on other registers, the same brand first.
- WakixCanada · 20 MG · Tablet · Knight Therapeutics INC.Same brand
- WakixCanada · 5 MG · Tablet · Knight Therapeutics INC.Same brand
- Wakix 18 MG Comprimidos Recubiertos con PeliculaSpain · 17,8 mg · comprimido recubierto con película · Bioprojet PharmaSame brand
- Wakix 4,5 MG Comprimidos Recubiertos con PeliculaSpain · 4.45 mg · comprimido recubierto con película · Bioprojet PharmaSame brand
- WakixEuropean Union · Bioprojet PharmaSame brand
- WakixCroatiaSame brand
- Wakix 18 mg filmomhulde tablettenNetherlands · Filmomhulde tablet · Bioprojet PharmaSame brand
- Wakix 4,5 mg filmomhulde tablettenNetherlands · Filmomhulde tablet · Bioprojet PharmaSame brand
- WAKIX 4,5 mgRomania · 4,5 mg · compr. film. · Bioprojet PharmaSame brand
- WakixUnited States · 17.8MG BASE, 4.45MG BASE · tablet · HarmonySame brand
- Ozawade 18 MG Comprimidos Recubiertos con PeliculaSpain · 20 mg · comprimido recubierto con película · Bioprojet PharmaSame form
- Ozawade 18 mg filmomhulde tablettenNetherlands · Filmomhulde tablet · Bioprojet PharmaSame form
- PitolisantUnited States · 4.45MG · tablet · MSN Laboratories Private LTDSame form
- PitolisantUnited States · 17.8MG · tablet · Novitium Pharma LLCSame form
- OzawadeEuropean Union · Bioprojet PharmaSame substance
- OzawadeCroatiaSame substance
Packs
| Pack | Code | Status |
|---|---|---|
| 4,5 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - FLACONE (HDPE) - 30 COMPRESSE | 044839013 | Autorizzata |
| 18 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - FLACONE (HDPE) - 30 COMPRESSE | 044839025 | Autorizzata |
| 18 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - FLACONE (HDPE) - 90 (3 X 30) COMPRESSE (CONFEZIONE MULTIPLA) | 044839037 | Autorizzata |
| 18 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - FLACONE (HDPE) - 90 COMPRESSE | 044839049 | Autorizzata |
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.
Agenzia Italiana del Farmaco (AIFA); https://drive.aifa.gov.it/farmaci/confezioni_fornitura.csv; HTTP Last-Modified Mon, 12 Oct 2026 23:02:44 GMT; acquired 2026-10-13T17:21:16.224007+00:00; native fields retained, source identifier and role projections are adaptations.
Licence: CC BY 4.0; AIFA published open-data catalog · Added 13 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
- Dosage form
- Compressa rivestita con film
- Register
- Italy (AIFA)
- Status
- Authorised
- Status in the register
- Autorizzata
- Registration
- AIC 044839
- Marketing authorisation holder
- Bioprojet Pharma
- ATC code
- N07XX11
- Group
- Nervous system
- Procedure
- Procedura Centralizzata
- Supply
- Medicinali soggetti a prescrizione medica limitativa, vendibili al pubblico su prescrizione di centri ospedalieri o di specialisti