Dysport 300U
*Company:
Ipsen Pharmaceuticals LimitedStatus:
UpdatedLegal 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 13 May 2026
File name
260513 - 476967-REC cl - DYS300 IE - Type IB 72 Hrs.pdf
Reasons for updating
- 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
Section 6.4 Special precautions for storage - update to include:
[...]
Unopened vials of Dysport can be used following a single exposure to temperatures up to 25°C for up to 72 hours, after which time the unopened vial should be stored in a refrigerator (2°C - 8°C) for the duration of shelf-life.
[...]
Section 10 Date of revision of the text - updated to 13/05/2026
Updated on 13 May 2026
File name
260513 - 476969-REC cl - DYS300 IE - Type IB 72 Hrs.pdf
Reasons for updating
- 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
Section 5 How to store Dysport updated to inlude:
[...]
Unopened vials of Dysport can be used following a single exposure to temperatures up to 25°C for up to 72 hours, after which time the unopened vial should be stored in a refrigerator (2°C - 8°C) for the duration of shelf-life.
[...]
Section 6 date of revision of text update to January 2026
Updated on 18 September 2025
File name
250917A ie-spc-clean-257_DYS300_IE.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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 7 (Marketing Authorisation Holder): update of MAH address to 70 rue Balard, 75015 Paris, France.
Section 10 (Date Of Revison Of The Text): update of revision date to 17/09/2025
Updated on 18 September 2025
File name
250917A ie-pl-clean-258_DYS300_IE.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Free text change information supplied by the pharmaceutical company
Section 6 - Marketing Authorisation Holder: update to MAH address
Updated on 22 July 2025
File name
250718A ie-spc-clean-243_DYS300_IE.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 22 July 2025
File name
250718A ie-pl-clean-244_DYS300_IE.pdf
Reasons for updating
- New PIL for new product
Ipsen Pharmaceuticals Limited
Address:
Blanchardstown Industrial Park, Blanchardstown, Dublin 15, IrelandMedical Information E-mail:
medinfo.uk-ie@ipsen.comTelephone:
0044 1753 627 777 , 01 8098256Stock Availability:
custservuk@ipsen.com