Fabrazyme 35 mg, powder for concentrate for solution for infusion
*Company:
Sanofi GenzymeStatus:
UpdatedLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 22 March 2024
File name
1.3.2 Mock-up PIL 35mg IENI (2).pdf
Reasons for updating
- Improved presentation of PIL
Updated on 19 March 2024
File name
1.3.1 PIL Text 35mg IENI (1).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 number
- Change to section 6 - manufacturer
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 not be renewed (A)
Updated on 15 May 2023
File name
1.3.1 SPC (IENI) (2).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 not be renewed (A)
Updated on 12 May 2023
File name
1.3.2 Mock-up PIL 35mg IENI.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 09 May 2023
File name
1.3.1 PIL Text 35mg 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 09 May 2023
File name
IE SPC Fabrazyme 35 and 5 mg.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 not be renewed (A)
Updated on 14 March 2023
File name
1.3.2 Mock-up PIL 35mg IE-NI (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 not be renewed (A)
Updated on 03 December 2021
File name
1.3.1 PIL text 35 mg IE-XI.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
- Change to section 6 - date of revision
Updated on 28 June 2021
File name
1.3.1 PIL text 35 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 not be renewed (A)
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 not be renewed (A)
File name
101382_Fabrazyme_Log-book_A5_V8 (1).pdf
Reasons for updating
- Add New Doc
Updated on 12 February 2021
File name
1.3.2 Mock-up 35mg PIL-IE (2).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 4.4 - 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
File name
1.3.1 PIL text 35mg 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
Free text change information supplied by the pharmaceutical company
Updated on 06 July 2020
File name
1.3.2 Mock-up 35mg PIL-IE (1).pdf
Reasons for updating
- XPIL Removed
File name
Home Infusion Manual for HCP.pdf
Reasons for updating
- Replace File
File name
Home Infustion Guide for Patients.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Correction of document
Updated on 18 February 2020
File name
1.3.2 Mock-up 35mg PIL-IE (1).pdf
Reasons for updating
- Improved presentation of PIL
File name
UK_IE_HCP Manual_CERZ-UK-10_10-2255a(1)a(1)_FINAL (3).pdf
Reasons for updating
- Add New Doc
File name
UK_IE_Patient Manual_CERZ-UK-10_10-2254a(1)a(1)_FINAL.pdf
Reasons for updating
- Add New Doc
Updated on 07 February 2020
File name
1.3.2 Mock-up 35mg PIL-IE.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 07 February 2020
File name
1.3.2 Mock-up 35mg PIL-IE.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 24 December 2019
File name
Fabrazyme 35mg PIL.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
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 35mg 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 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
File name
Fabrazyme.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 18 December 2017
File name
PIL_14649_54.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 not be renewed (A)
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 not be renewed (A)
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 17 July 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
- Introduction of new strength
Updated on 15 May 2017
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
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