Zejula 100 mg hard capsules

  • Name:

    Zejula 100 mg hard capsules

  • Company:
    info
  • Active Ingredients:

    Niraparib tosylate monohydrate

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 02/07/19

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Summary of Product Characteristics last updated on medicines.ie: 2/7/2019
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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Tesaro UK Limited

Tesaro UK Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Varuby 90 mg film-coated tablets Active Ingredients Rolapitant hydrochloride monohydrate
Medicine Name Zejula 100 mg hard capsules Active Ingredients Niraparib tosylate monohydrate
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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 July 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to date of revision

Updated on 2 July 2019 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 8 January 2018 SmPC

Reasons for updating

  • Product/presentation re-marketed

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

$0In 6.5 addition of pack size:$0$0$0$0$0Aclar/PVC/aluminiumfoil perforated unit dose blisters in cartons of 84 × 1, 56 × 1 and 28 × 1 hardcapsules.$0$0 $0$0Not all pack sizesmaybe marketed.$0

Updated on 8 January 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 2 January 2018 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 20 December 2017 PIL

Reasons for updating

  • New PIL for new product