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Fabrazyme 5 mg, powder for concentrate for solution for infusion *
Pharmacy Only: Prescription

  • Company:

    Sanofi Genzyme

  • Status:

    Updated

  • Legal Category:

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

  • Active Ingredient(s):

    Agalsidase Beta

    *Additional information is available within the SPC or upon request to the company

Updated on 09 May 2023

File name

645a5880f3bec.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

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

Updated on 09 May 2023

File name

645a581a1fa1e.pdf

Reasons for updating

  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - manufacturer

Updated on 14 March 2023

File name

64102ecc68e85.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 14 March 2023

File name

64102ddc7117d.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 25 May 2022

File name

628e2d7d6e442.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.6 - Special precautions for disposal and other handling

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

EDM Updated on 02 February 2022

File name

101382_Fabrazyme_Log-book_A5_V8 (1)_1643812142.pdf

Reasons for updating

  • Add New Doc

Updated on 14 December 2021

File name

1.3.1 PIL text 5 mg IE-XI (3)_1639488653.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 28 June 2021

File name

1.3.1 PIL text 5 mg IE_1624891121.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for
  • 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
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 28 June 2021

File name

1.3.1 SPC IE (3)_1624891000.pdf

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling

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

EDM Updated on 08 April 2021

File name

Fabrazyme_Patients_Manual_1617875728.pdf

Reasons for updating

  • Replace File

EDM Updated on 08 April 2021

File name

Fabrazyme_Healthcare_Professionals_Manual_1617875728.pdf

Reasons for updating

  • Replace File

Updated on 06 April 2021

File name

Clean - 1.3.1 SPC IE (1)_1617705626.pdf

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

File name

1.3.2 Mock-up 5mg PIL-IE (3)_1613132591.pdf

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

File name

1.3.1 SPC IE (1)_1606131759.pdf

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

File name

1.3.1 PIL text 5mg IE_1606131721.pdf

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

File name

IE POILLL_1582121142.pdf

Reasons for updating

  • XPIL Removed

Updated on 19 February 2020

File name

IE POILLL_1582121142.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 18 February 2020

File name

1.3.2 Mock-up 5mg PIL-IE (1)_1581086256.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 07 February 2020

File name

1.3.2 Mock-up 5mg PIL-IE (1)_1581086256.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 07 February 2020

File name

1.3.2 Mock-up 5mg PIL-IE_1581079083.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 24 December 2019

File name

Fabrazyme 5mg PIL_1577188949.pdf

Reasons for updating

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

EDM Updated on 11 October 2019

File name

IRE-ELEC Patient Manual-FINAL-Mar18_1570792846.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 11 October 2019

File name

IRE-ELEC HCP Manual-FINAL-Mar18_1570792846.pdf

Reasons for updating

  • Add New Doc

Updated on 16 September 2019

File name

PIL (IE)_1568650087.pdf

Reasons for updating

  • New PIL for medicines.ie

Updated on 07 January 2019

File name

PIL Fabrazyme 5mg powder_1546865534.pdf

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

File name

SPC Fabrazyme 5 and 35mg powder_1546865709.pdf

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

File name

PIL_14650_566.pdf

Reasons for updating

  • New PIL for new product

Updated on 18 December 2017

Reasons for updating

  • Improved presentation of PIL

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