Zykadia 150 mg hard capsules

  • Name:

    Zykadia 150 mg hard capsules

  • Company:
    info
  • Active Ingredients:

    Ceritinib

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 10/04/19

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Summary of Product Characteristics last updated on medicines.ie: 10/4/2019
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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Novartis Ireland Limited

Novartis Ireland Limited

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51 - 75 of 116 items.Total: 5 pages

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 10 April 2019 PIL

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - what the product contains

Updated on 10 April 2019 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company

Minor editorial changes to Sections 4.2, 6.1 and 6.5.

Updated on 21 March 2019 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink

Updated on 21 March 2019 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

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

Free text change information supplied by the pharmaceutical company

Revision of recommendations for concomitant use of Zykadia with CYP3A and CYP2C9 substrates based on A2103 drug interaction study results.

Changes to the list of examples of CYP3A substrates with narrow therapeutic index (NTI) {addition of alfuzosin, amiodarone, dihydroergotamine, quetiapine, lovastatin, simvastatin, sildenafil, midazolam, triazolam and deletion of astemizole}

Updated on 4 September 2018 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 26 July 2018 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.2 - Pharmacokinetic properties

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

Updated on 3 July 2018

Updated on 23 May 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 16 September 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 16 September 2015 PIL

Reasons for updating

  • Change to side-effects

Updated on 3 September 2015 PIL

Reasons for updating

  • Introduction of new pack/pack size

Updated on 10 June 2015 PIL

Reasons for updating

  • New PIL for new product