Fabrazyme 5 mg, powder for concentrate for solution for infusion
*Company:
Sanofi GenzymeStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 01 April 2025
File name
1.3.1 SPC IE (2).pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 01 April 2025
File name
1.3.1 PIL Text 5mg IE (1).pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
Updated on 27 March 2025
File name
1.3.1 SPC IE (1).pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Improved presentation of SPC
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 27 March 2025
File name
1.3.1 PIL Text 5mg IE.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Improved presentation of PIL
Updated on 19 August 2024
File name
1.3.1 SPC (IENI).pdf
Reasons for updating
- Change to section 9 - Date of first authorisation/renewal of the authorisation
Legal category:Product subject to medical prescription which may be renewed (B)
File name
Fabrazyme_Healthcare_Professionals_Manual_2024_Clean_April date.pdf
Reasons for updating
- Replace File
File name
Fabrazyme_Patients_Manual_2024_Clean_April date.pdf
Reasons for updating
- Replace File
File name
Fabrazyme IE_Logbook Home Infusion_2024_FINAL.pdf
Reasons for updating
- Add New Doc
File name
Fabrazyme_Patients_Manual_2024_FINAL.pdf
Reasons for updating
- Add New Doc
File name
Fabrazyme_Healthcare_Professionals_Manual_2024_FINAL.pdf
Reasons for updating
- Add New Doc
Updated on 22 March 2024
File name
1.3.2 Mock-up PIL 5mg IENI (1).pdf
Reasons for updating
- Improved presentation of PIL
Updated on 19 March 2024
File name
1.3.1 SPC (IENI) (3).pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 19 March 2024
File name
1.3.1 PIL Text 5mg IENI.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 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
Updated on 09 May 2023
File name
1.3.1 SPC (IENI).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
1.3.2 Mock-up PIL 5mg IENI.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
1.3.2 Mock-up PIL 5mg IE-NI (3).pdf
Reasons for updating
- Improved presentation of PIL
Updated on 14 March 2023
File name
1.3.2 Mock-up PIL (4) (1).pdf
Reasons for updating
- Improved presentation of PIL
Updated on 25 May 2022
File name
IE SPC Fabrazyme 35 and 5 mg.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)
File name
101382_Fabrazyme_Log-book_A5_V8 (1).pdf
Reasons for updating
- Add New Doc
Updated on 14 December 2021
File name
1.3.1 PIL text 5 mg IE-XI (3).pdf
Reasons for updating
- Improved presentation of PIL
Updated on 28 June 2021
File name
1.3.1 PIL text 5 mg IE.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).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)
File name
Fabrazyme_Healthcare_Professionals_Manual.pdf
Reasons for updating
- Replace File
File name
Fabrazyme_Patients_Manual.pdf
Reasons for updating
- Replace File
Updated on 06 April 2021
File name
Clean - 1.3.1 SPC IE (1).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).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).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.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.pdf
Reasons for updating
- XPIL Removed
Updated on 19 February 2020
File name
IE POILLL.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 18 February 2020
File name
1.3.2 Mock-up 5mg PIL-IE (1).pdf
Reasons for updating
- Improved presentation of PIL
Updated on 07 February 2020
File name
1.3.2 Mock-up 5mg PIL-IE (1).pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 07 February 2020
File name
1.3.2 Mock-up 5mg PIL-IE.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 24 December 2019
File name
Fabrazyme 5mg PIL.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
File name
IRE-ELEC HCP Manual-FINAL-Mar18.pdf
Reasons for updating
- Add New Doc
File name
IRE-ELEC Patient Manual-FINAL-Mar18.pdf
Reasons for updating
- Add New Doc
Updated on 16 September 2019
File name
PIL (IE).pdf
Reasons for updating
- New PIL for medicines.ie
Updated on 07 January 2019
File name
PIL Fabrazyme 5mg powder.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.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
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
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
Sanofi Genzyme
Address:
CITYWEST BUSINESS CAMPUS, DUBLIN 24, IRELANDMedical Information E-mail:
iemedinfo@sanofi.comTelephone:
+353 1 4035600