Raxone 150 mg film-coated tablets

  • Name:

    Raxone 150 mg film-coated tablets

  • Company:
    info
  • Active Ingredients:

    Idebenone

  • Legal Category:

    Product subject to restricted prescription (C)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 05/02/20

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Summary of Product Characteristics last updated on medicines.ie: 3/2/2020
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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Chiesi Limited

Chiesi Limited

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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 5 February 2020 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 5 February 2020 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect

Free text change information supplied by the pharmaceutical company

There was an error in the previous versions submitted they were missing local information under Section 4 which refers to reporting side effects using the "the national reporting system listed in Appendix V" these have now been completed with  information specific to Ireland 

Updated on 5 February 2020 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect

Free text change information supplied by the pharmaceutical company

Section 4 refers to reporting side effects using the "the national reporting system listed in Appendix V" which have now been updated to include information specific to Ireland

Updated on 4 February 2020 PIL

Reasons for updating

  • New PIL for new product

Updated on 3 February 2020 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to restricted prescription (C)