Kanuma

  • Name:

    Kanuma

  • Company:
    info
  • Active Ingredients:

    Sebelipase alfa

  • Legal Category:

    Product subject to restricted prescription (C)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 07/05/20

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 7/5/2020
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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Alexion Pharma UK Ltd

Alexion Pharma UK Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name Kanuma Active Ingredients Sebelipase alfa
Medicine Name Soliris Active Ingredients Eculizumab
Medicine Name Strensiq 100mg/ml Active Ingredients Asfotase alfa
Medicine Name Strensiq 40mg/ml Active Ingredients Asfotase alfa
Medicine Name Ultomiris Active Ingredients Ravulizumab
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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 7 May 2020 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - use in children/adolescents
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 7 May 2020 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - use in children/adolescents
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

changes due to renewal of the marketing authorisation.

Updated on 7 May 2020 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of first authorisation/renewal of the authorisation

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

This change is purely related to renewal of the marketing authorisation

Updated on 30 April 2020 Ed-HCP

Reasons for updating

  • Add New Doc

Free text change information supplied by the pharmaceutical company

Update of Med-info details 

Updated on 18 July 2018

Updated on 18 July 2018 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Product information was updated to add safety features on marketed packaging.  The date of revision of the text is 14June2018.  

Updated on 13 June 2018 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 8 March 2018 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Correction of spelling/typing errors

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

$0$0$0Reporting of suspected adverse reactions $0$0Reporting suspected adverse reactions after authorisation ofthe medicinal product is important. It allows continued monitoring of thebenefit/risk balance of the medicinal product. Healthcare professionals areasked to report any suspected adverse reactions via the national reportingsystem detailed below;$0$0United Kingdom: Yellow card system, viawww.mhra.gov.uk/yellowcard. $0$0Ireland: HPRA Pharmacovigilance, Website: www.hpra.ie;E-mail: medsafety@hpra.ie. $0$0Adverse events should also be reported to Alexion Pharma UKLtd on uk.adverseevents@alexion.com, Freephone (UK): 0800 321 3902, Freephone(Ireland): 1 800 936 544.  $0$0$0$0Also, correction to Legal Category $0

Updated on 8 March 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to restricted prescription (C)

Updated on 16 February 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 16 February 2018 PIL

Reasons for updating

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

Updated on 12 October 2015 PIL

Reasons for updating

  • Change of licence holder

Updated on 12 October 2015 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Marketing Authorization Holder has changed from Synageva BioPharma Limited, to Alexion Europe SAS.

Updated on 23 September 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 16 September 2015 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

None provided