Fabrazyme 5 mg, powder for concentrate for solution for infusion

Product Information *

  • Company:

    Sanofi Genzyme
  • Status:

    No Recent Update
  • Active Ingredients * :

    *Additional information is available upon request

  • Legal Category:

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

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 08 April 2021

Reasons for updating

  • Replace document

Updated on 08 April 2021

Reasons for updating

  • Replace document

Updated on 06 April 2021

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

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

Updated on 12 February 2021

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

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

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

Updated on 23 November 2020

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 06 July 2020

Reasons for updating

  • XPIL Removed

Updated on 19 February 2020

Reasons for updating

  • Improved presentation of PIL

Updated on 18 February 2020

Reasons for updating

  • Improved presentation of PIL

Updated on 07 February 2020

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 07 February 2020

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 24 December 2019

Reasons for updating

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

Updated on 11 October 2019

Reasons for updating

  • Add New Doc

Updated on 11 October 2019

Reasons for updating

  • Add New Doc

Updated on 16 September 2019

Reasons for updating

  • New PIL for medicines.ie

Updated on 07 January 2019

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 07 January 2019

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

Reasons for updating

  • Improved presentation of PIL

Updated on 18 December 2017

Reasons for updating

  • New PIL for new product

Updated on 11 December 2017

Reasons for updating

  • New SPC for new product

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

Updated on 11 December 2017

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 03 November 2017

Reasons for updating

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

Updated on 15 May 2017

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

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

Reasons for updating

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

Updated on 31 August 2012

Reasons for updating

  • Removal/change of distributor

Updated on 15 December 2011

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

Reasons for updating

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

Updated on 16 April 2010

Reasons for updating

  • New PIL for medicines.ie