ILUVIEN 190 micrograms intravitreal implant in applicator
*Company:
Alimera Sciences Europe LimitedStatus:
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 26 September 2023
File name
IE-UK PIL -Jul-23.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 12 September 2023
File name
ILUVIEN SPC, Ireland, Sep 2023 .pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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 not be renewed (A)
Updated on 26 October 2022
File name
IE-UK PIL Aug-22.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
File name
PATIEN~1.mpga
Reasons for updating
- Add New Audio
File name
IE HCP Administration Video, 012022.mp4
Reasons for updating
- Add New Video
File name
IE Patient Educational Material (A4), 012022.pdf
Reasons for updating
- Replace File
File name
IE Patient Educational Material (A5), 012022.pdf
Reasons for updating
- Replace File
File name
IE HCP Administration Guide, 012022.pdf
Reasons for updating
- Replace File
Updated on 04 November 2021
File name
IE-UK PIL Jun-21.pdf
Reasons for updating
- XPIL Created
Updated on 04 November 2021
File name
IE-UK PIL Jun-21.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
Revision of existing warning and precaution for implant migration in Section 2, with related update to Section 4 Possible Side Effects.
Updated on 04 November 2021
File name
ILUVIEN SPC, Ireland Sep 2021.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 5.1 - Pharmacodynamic properties
- 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 4.4: Revision of the existing special warning and precaution for device dislocation (implant migration)
Section 4.8: Addition of corneal oedema associated to the existing device dislocation entry in the 'Tabulated list of adverse events'
Section 5.1: Addition of paragraph beneath Figure 3 reflecting completion of the post-approval safety registry study.
Section 10: Revision date updated.
Updated on 06 January 2020
File name
IE SmPC_june 2019.pdf
Reasons for updating
- Improved presentation of SPC
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Replacement of version containing HPRA case numbers with the QRD approved version
Updated on 10 December 2019
File name
Patient Information Leaflet.pdf
Reasons for updating
- Change to section 6 - date of revision
- Addition of manufacturer
File name
IE Patient Material A4.pdf
Reasons for updating
- Add New Doc
File name
IE Patient Material A5.pdf
Reasons for updating
- Add New Doc
File name
IE Administration guide For Physicians.pdf
Reasons for updating
- Add New Doc
Updated on 19 September 2019
File name
SmPC_june 2019.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 19 September 2019
File name
PIL_mar 2019_HPRA issued.pdf
Reasons for updating
- New PIL for new product