Wakix 4.5 mg film-coated tablets

*
Pharmacy Only: Prescription
  • Company:

    Bioprojet Pharma
  • Status:

    No Recent Update
  • Legal 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 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)