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Fabrazyme 35 mg, powder for concentrate for solution for infusion

  • Name:

    Fabrazyme 35 mg, powder for concentrate for solution for infusion

  • Company:
    info
  • Active Ingredients:

    Agalsidase beta

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 12/02/21

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Summary of Product Characteristics last updated on medicines.ie: 6/4/2021

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Sanofi Genzyme

Sanofi Genzyme logo_1556886599

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1 - 0 of 21 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 8 April 2021 Ed-HCP

Reasons for updating

  • Replace document

Updated on 8 April 2021 Ed-Ptnt

Reasons for updating

  • Replace document

Updated on 6 April 2021 SPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

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

Updated on 3 March 2021 Ed-Both

Reasons for updating

  • Add New Doc

Updated on 12 February 2021 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 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 2 - excipient warnings

Updated on 23 November 2020 SPC

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 5.1 - Pharmacodynamic properties

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

Updated on 23 November 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 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 2 - excipient warnings

Free text change information supplied by the pharmaceutical company

  1.  

Updated on 6 July 2020 PIL

Reasons for updating

  • XPIL Removed

Updated on 10 June 2020 Ed-HCP

Reasons for updating

  • Replace document

Updated on 10 June 2020 Ed-Ptnt

Reasons for updating

  • Replace document

Free text change information supplied by the pharmaceutical company

Correction of document

Updated on 18 February 2020 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 10 February 2020 Ed-HCP

Reasons for updating

  • Add New Doc

Updated on 10 February 2020 Ed-Ptnt

Reasons for updating

  • Add New Doc

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 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 SPC

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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.7    Effects on ability to drive and use machines

 

Fabrazyme may have a minor influence on the ability to drive or use machines on the day of Fabrazyme administration because dizziness, somnolence, vertigo and syncope may occur (see section 4.8).

 

7.       MARKETING AUTHORISATION HOLDER

 

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

 

Updated on 18 May 2018 PIL

Reasons for updating

  • Change to section 6 - manufacturer

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 SPC

Reasons for updating

  • New SPC for new product

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

Updated on 11 December 2017 SPC

Reasons for updating

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

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

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 17 July 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
  • Introduction of new strength

Updated on 15 May 2017 SPC

Reasons for updating

  • Addition of joint SPC covering all presentations

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 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