Wakix 18 mg film-coated tablets

  • Name:

    Wakix 18 mg film-coated tablets

  • Company:
    info
  • Active Ingredients:

    Pitolisant hydrochloride

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Summary of Product Characteristics last updated on medicines.ie: 2/2/2021
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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Bioprojet Pharma

BP Pharma logo_1612263478

Company Products

Medicine NameActive Ingredients
Medicine Name Anapen 300 micrograms in 0.3ml solution for injection in a pre-filled syringe Active Ingredients Epinephrine
Medicine Name Anapen 500 micrograms in 0.3ml solution for injection in a pre-filled syringe Active Ingredients Epinephrine
Medicine Name Anapen Junior 150 micrograms in 0.3ml solution for injection in a pre-filled syringe Active Ingredients Epinephrine
Medicine Name Wakix 18 mg film-coated tablets Active Ingredients Pitolisant hydrochloride
Medicine Name Wakix 4.5 mg film-coated tablets Active Ingredients Pitolisant hydrochloride
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When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 2 February 2021 SPC

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 8 October 2020 SPC

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 SPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)