Wakix 4.5 mg film-coated tablets
*Company:
Bioprojet PharmaStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
This medicinal product is subject to additional monitoring.
*Additional information is available within the SPC or upon request to the company
Updated on 03 October 2024
File name
ema-combined-h-2616-en.pdf
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 02 February 2021
File name
ema-combined-h-2616-en.pdf
Reasons for updating
- Change to section 9 - Date of first authorisation/renewal of the authorisation
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Renewal of Marketing Authorisation from time-gated to unlimited end date.
Updated on 08 October 2020
File name
Wakix_ema-combined-h-2616-en_SPC_Only.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 20 August 2019
File name
ema-combined-h-2616-en.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)