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Aldurazyme 100 U/ml concentrate for solution for infusion

*
Pharmacy Only: Prescription

  • Company:

    Sanofi Genzyme

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Laronidase

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

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Updated on 01 April 2025

File name

1.3.1.1 Summary of Product Characteristics (SmPC) Aldurazyme IE (2).pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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

1.3.2 Mock-up PIL IE (2).pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - marketing authorisation holder

Updated on 01 April 2025

File name

1.3.2 Mock-up PIL IE (2).pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number

Updated on 01 April 2025

File name

1.3.1.1 Summary of Product Characteristics (SmPC) Aldurazyme IE (2).pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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 25 February 2025

File name

1.3.1.1 Summary of Product Characteristics (SmPC) Aldurazyme IE.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 25 February 2025

File name

1.3.2 Mock-up PIL IE.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder

Updated on 24 September 2024

File name

1.3.1.1 Summary of Product Characteristics (SmPC).pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 14 May 2024

File name

1.3.2 Mock-up PIL IE-XI.pdf

Reasons for updating

  • Previous version of PIL reinstated

Updated on 14 May 2024

File name

1.3.2.1 Mock-up Leaflet.pdf

Reasons for updating

  • Change to section 3 - dose and frequency
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 3 - duration of treatment
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 29 January 2024

File name

1.3.2 Mock-up PIL IE-XI (5).pdf

Reasons for updating

  • Change to section 3 - dose and frequency
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 3 - duration of treatment
  • Change to section 3 - overdose, missed or forgotten doses

Updated on 29 January 2024

File name

1.3.1.1 SmPC IE-MT-UKNI (4).pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text

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

Updated on 03 May 2023

File name

1.3.1.1 SmPC IE-MT-UKNI (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 be renewed (B)

Updated on 03 May 2023

File name

1.3.2 Mock-up PIL IE-XI (3).pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 26 April 2023

File name

1.3.1 PIL Text IE-XI (1).pdf

Reasons for updating

  • Correction of spelling/typing errors

Updated on 06 April 2023

File name

1.3.1 PIL Text IE-XI.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 3 - dose and frequency
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 3 - duration of treatment
  • Change to section 3 - overdose, missed or forgotten doses
  • 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 06 April 2023

File name

1.3.1.1 SmPC IE-MT-UKNI (1).pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 6.6 - Special precautions for disposal and other handling

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

Updated on 19 November 2021

File name

1.3.1.3 Leaflet text 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 02 February 2021

File name

ireland.pdf

Reasons for updating

  • Correction of spelling/typing errors

Updated on 08 January 2021

File name

al.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

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

Updated on 08 January 2021

File name

ALDURAZYME IE Mock-up Leaflet Waterford.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
  • 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

Updated on 06 July 2020

File name

IE.pdf

Reasons for updating

  • XPIL Removed

Updated on 23 April 2020

File name

IE.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 11 March 2020

File name

ALD.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 15 March 2019

File name

PIL- Aldurazyme Waterford.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 14 January 2019

File name

PIL Aldurazyme.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 14 January 2019

File name

SPC Aldurazyme 100ml .pdf

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

7.       MARKETING AUTHORISATION HOLDER

 

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

 

 

Updated on 11 December 2017

File name

PIL_14666_22.pdf

Reasons for updating

  • New PIL for new product

Updated on 11 December 2017

Reasons for updating

  • Change to section 6 - marketing authorisation number

Updated on 13 September 2017

Reasons for updating

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

Updated on 23 December 2015

Reasons for updating

  • New SPC for new product

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

Updated on 23 December 2015

Reasons for updating

  • Removal of black triangle
  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company



Black Triangle, additional monitoring status has now been removed.

Section 5.1: The reference to the license having been approved under “exceptional circumstances” has been deleted.

Updated on 23 December 2015

Reasons for updating

  • Removal of black triangle

Updated on 09 December 2014

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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

Section 4.8: how to report a side effect; HPRA contact details updated and Malta reporting details included

Section 10: Revision of the text date has been included (11/2014).

Updated on 09 December 2014

Reasons for updating

  • Change to further information section
  • Addition of information on reporting a side effect.

Updated on 22 September 2014

Reasons for updating

  • Addition of black triangle
  • 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)

Free text change information supplied by the pharmaceutical company

- inclusion of black triangle status header in section 1 of the SPC and advisory on reporting adverse events to health authorities in section 4.8 (Update to QRD template 9.0).

Updated on 22 September 2014

Reasons for updating

  • Addition of information on reporting a side effect.
  • Addition of black triangle

Updated on 08 March 2013

Reasons for updating

  • Change to side-effects
  • Change to information about pregnancy or lactation

Updated on 07 March 2013

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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

  • Update QRD template version 8.0
  • Addition of safety terms “laryngeal oedema” and “oedema peripheral” in section 4.8 of the SmPC (and accordingly in package leaflet)
  • Linguistic changes

Updated on 25 June 2012

Reasons for updating

  • Change of distributor details

Updated on 16 December 2011

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Improved electronic presentation

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

Free text change information supplied by the pharmaceutical company

In section 4.8 (undesirable effects), Hypoxia added
The main changes are related to an update to QRD template version 7.3.1.

Updated on 14 December 2011

Reasons for updating

  • Change to improve clarity and readability

Updated on 07 April 2011

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 11 May 2010

Reasons for updating

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

Updated on 10 May 2010

Reasons for updating

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

Changes made to the following sections:

Section 4.2         Posology and method of administration - Insertion of text for paediatric population.  
Section 4.8         Undesirable effects  - Inclusion of 'erythema'
Section  10.         DATE OF REVISION OF THE TEXTChange of date of revision of text.

Updated on 27 April 2010

Reasons for updating

  • New SPC for medicines.ie

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 27 April 2010

Reasons for updating

  • New PIL for medicines.ie

Sanofi Genzyme

Sanofi Genzyme