Alluzience, 200 Speywood units/ml, solution for injection
*Company:
Galderma International S.A.S. c/o Galderma (U.K) Ltd.Status:
No Recent UpdateLegal 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 19 April 2023
File name
230405A ie-pl-clean-47_ALLUZIENCE-Ireland - version for external use by Galderma.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
SmPC (and PIL) updated to reflect HPRA approval (5Apr2023) for Type II MRP safety variation for warnings and precautions (muscle atrophy) and adverse effects (post-marketing experience: hypoaesthesia and muscle atrophy).
Updated on 19 April 2023
File name
230405A ie-spc-clean-48_ALLUZIENCE-Ireland - version for external use by Galderma.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 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
SmPC (and PIL) updated to reflect HPRA approval (5Apr2023) for Type II MRP safety variation for warnings and precautions (muscle atrophy) and adverse effects (post-marketing experience: hypoaesthesia and muscle atrophy).
Updated on 01 January 2023
File name
221130 ie-pl-clean-43_ALLUZIENCE-Ireland - version for external use by Galderma.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Consolidated update to reflect HPRA (national phase) approval for Type II MRP variations to 1) add 'dry eye' warning [SmPC section 4.4] - approved 22Nov2022 and 2) to update the storage condition for the vial outside refrigerator [SmPC section 6.4] - approved 30Nov2022, together with consequential updating of the PIL.
Updated on 01 January 2023
File name
221130 ie-spc-clean-44_ALLUZIENCE-Ireland - version for external use by Galderma.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.4 - Special precautions for storage
- 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
Consolidated update to reflect HPRA (national phase) approval for Type II MRP variations to 1) add 'dry eye' warning [SmPC section 4.4] - approved 22Nov2022 and 2) to update the storage condition for the vial outside refrigerator [SmPC section 6.4] - approved 30Nov2022, together with consequential updating of the PIL.
Updated on 08 August 2022
File name
220807A ie-pl-clean-25_ALLUZIENCE-Ireland - version for external use by Galderma.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Type IB MRP variation approved 8Jul2022 (in Ireland) for the addition of the bundle/multi-pack containing 12 vials.
Updated on 08 August 2022
File name
220807A ie-spc-clean-26_ALLUZIENCE-Ireland - version for external use by Galderma.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- 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
Type IB MRP variation approved 8Jul2022 (in Ireland) for the addition of the bundle/multi-pack containing 12 vials.
Updated on 15 June 2022
File name
20220520 Alluzience Ireland approved PIL.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
Initial PIL upload.
Updated on 14 June 2022
File name
20210910 Alluzience Ireland approved SmPC.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Initial upload to medicines.ie.