Aldurazyme 100 U/ml concentrate for solution for infusion

  • Name:

    Aldurazyme 100 U/ml concentrate for solution for infusion

  • Company:
    info
  • Active Ingredients:

    Laronidase

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 23/04/20

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 14/1/2019

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Sanofi Genzyme

Sanofi Genzyme logo_1556886599

Company Products

Medicine NameActive Ingredients
Medicine Name Aldurazyme 100 U/ml concentrate for solution for infusion Active Ingredients Laronidase
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Medicine Name Thyrogen 0.9 mg powder for solution for injection Active Ingredients Thyrotropin alfa
1 - 0 of 19 items.Total: Infinity pages

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 23 April 2020 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 11 March 2020 PIL

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 15 March 2019 PIL

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 14 January 2019 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 14 January 2019 SmPC

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 PIL

Reasons for updating

  • New PIL for new product

Updated on 11 December 2017 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation number

Updated on 13 September 2017 PIL

Reasons for updating

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

Updated on 23 December 2015 SmPC

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 PIL

Reasons for updating

  • Removal of black triangle

Updated on 23 December 2015 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 9 December 2014 SmPC

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 9 December 2014 PIL

Reasons for updating

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

Updated on 22 September 2014 SmPC

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 PIL

Reasons for updating

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

Updated on 8 March 2013 PIL

Reasons for updating

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

Updated on 7 March 2013 SmPC

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 PIL

Reasons for updating

  • Change of distributor details

Updated on 16 December 2011 SmPC

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 PIL

Reasons for updating

  • Change to improve clarity and readability

Updated on 7 April 2011 PIL

Reasons for updating

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

Updated on 11 May 2010 PIL

Reasons for updating

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

Updated on 10 May 2010 SmPC

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 SmPC

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 PIL

Reasons for updating

  • New PIL for medicines.ie