Wakix 18 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 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.
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)
Free text change information supplied by the pharmaceutical company
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects - how to report a side effect
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)