Fabrazyme 5 mg, powder for concentrate for solution for infusion

  • Name:

    Fabrazyme 5 mg, powder for concentrate for solution for infusion

  • Company:
    info
  • Active Ingredients:

    Agalsidase beta

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 06/07/20

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Summary of Product Characteristics last updated on medicines.ie: 7/1/2019

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Sanofi Genzyme

Sanofi Genzyme logo_1556886599

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Medicine Name Fabrazyme 35 mg, powder for concentrate for solution for infusion Active Ingredients Agalsidase beta
Medicine Name Fabrazyme 5 mg, powder for concentrate for solution for infusion Active Ingredients Agalsidase beta
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1 - 0 of 19 items.Total: Infinity 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 6 July 2020 PIL

Reasons for updating

  • XPIL Removed

Updated on 19 February 2020 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 18 February 2020 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 7 February 2020 PIL

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 7 February 2020 PIL

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 24 December 2019 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - manufacturer

Updated on 11 October 2019 Ed-Ptnt

Reasons for updating

  • Add New Doc

Updated on 11 October 2019 Ed-HCP

Reasons for updating

  • Add New Doc

Updated on 16 September 2019 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 7 January 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder

Updated on 7 January 2019 SmPC

Reasons for updating

  • Change to section 4.9 - Overdose
  • Change to section 7 - Marketing authorisation holder

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

Free text change information supplied by the pharmaceutical company

4.9    Overdose

 

In clinical trials doses up to 3 mg/kg body weight were used.

 

7.       MARKETING AUTHORISATION HOLDER

 

Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands

Updated on 18 December 2017 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 18 December 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 11 December 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 11 December 2017 SmPC

Reasons for updating

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

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

Free text change information supplied by the pharmaceutical company

Date of revision of the text

Updated on 3 November 2017 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 15 May 2017 SmPC

Reasons for updating

  • Addition of joint SPC covering all presentations

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 13 February 2017 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 - use in children and adolescents
  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision
  • Introduction of new strength

Updated on 19 August 2014 PIL

Reasons for updating

  • Addition of manufacturer
  • Addition of information on reporting a side effect.

Updated on 31 August 2012 PIL

Reasons for updating

  • Removal/change of distributor

Updated on 15 December 2011 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 17 June 2011 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 16 April 2010 PIL

Reasons for updating

  • New PIL for medicines.ie