Aldurazyme 100 U/ml concentrate for solution for infusion
- Name:
Aldurazyme 100 U/ml concentrate for solution for infusion
- Company:
Sanofi Genzyme
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 02/02/21
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Sanofi Genzyme
Company Products
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 2 February 2021 PIL
Reasons for updating
- Correction of spelling/typing errors
Updated on 8 January 2021 SPC
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 8 January 2021 PIL
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 6 July 2020 PIL
Reasons for updating
- XPIL Removed
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 SPC
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 SPC
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 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 9 December 2014 PIL
Reasons for updating
- Change to further information section
- Addition of information on reporting a side effect.
Updated on 9 December 2014 SPC
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 22 September 2014 SPC
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 SPC
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 SPC
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
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 SPC
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
Section 4.2 Posology and method of administration - Insertion of text for paediatric population.
Updated on 27 April 2010 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 27 April 2010 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may be renewed (B)