Aldurazyme 100 U/ml 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 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
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
Section 4.2 Posology and method of administration - Insertion of text for paediatric population.
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
Updated on 27 April 2010
Reasons for updating
- New PIL for medicines.ie