ILUVIEN 190 micrograms intravitreal implant in applicator *
Pharmacy Only: Prescription

EDM Updated on 14 February 2022

File name

PATIEN~1_1644839977.mpga

Reasons for updating

  • Add New Audio

EDM Updated on 09 February 2022

File name

IE HCP Administration Video, 012022_1644403136.mp4

Reasons for updating

  • Add New Video

EDM Updated on 09 February 2022

File name

IE Patient Educational Material (A4), 012022_1644401074.pdf

Reasons for updating

  • Replace File

EDM Updated on 09 February 2022

File name

IE Patient Educational Material (A5), 012022_1644401074.pdf

Reasons for updating

  • Replace File

EDM Updated on 09 February 2022

File name

IE HCP Administration Guide, 012022_1644400223.pdf

Reasons for updating

  • Replace File

Updated on 04 November 2021

File name

IE-UK PIL Jun-21_1636062840.pdf

Reasons for updating

  • XPIL Created

Updated on 04 November 2021

File name

IE-UK PIL Jun-21_1636061613.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_1636030469.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_1578319206.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_1575989034.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Addition of manufacturer

EDM Updated on 19 September 2019

File name

IE Patient Material A4_1568892303.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 19 September 2019

File name

IE Patient Material A5_1568892303.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 19 September 2019

File name

IE Administration guide For Physicians_1568892303.pdf

Reasons for updating

  • Add New Doc

Updated on 19 September 2019

File name

SmPC_june 2019_1568891308.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_1568890877.pdf

Reasons for updating

  • New PIL for new product