Emgality 120 mg solution for injection

*
Pharmacy Only: Prescription
  • Company:

    Eli Lilly and Company (Ireland) Limited
  • Status:

    Updated
  • Legal 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

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Updated on 24 October 2025

File name

Emgality_SmPC_Oct25_IE-MT.pdf

Reasons for updating

  • 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

Updated EMA website link at end of SmPC

Updated on 24 October 2025

File name

Emgality_PIL_Oct25_IE-MT.pdf

Reasons for updating

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

Updated on 05 September 2025

File name

Emgality_PIL_EM038_Jul24_IE-MT.pdf

Reasons for updating

  • XPIL Updated

Updated on 04 September 2025

File name

Emgality_PIL_EM038_Jul24_IE-MT.pdf

Reasons for updating

  • XPIL Created

Updated on 11 February 2025

File name

Emgality_PIL_EM038_Jul24_IE-MT.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 03 February 2025

File name

Emgality_PIL_EM038_Jul24_IE-MT.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Improved presentation of PIL

Updated on 03 February 2025

File name

Emgality_SmPC_EM037_Sep23_IE-MT.pdf

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Improved presentation of SPC

Legal category:Product subject to medical prescription which may not be renewed (A)

EDM Updated on 14 September 2023

File name

Emgality_pen_IFU_EM033_Sep2023_IE-NI-MT.pdf

Reasons for updating

  • Replace File

Updated on 14 September 2023

File name

Emgality_SmPC_EM031_Sep23_IE-MT-NI.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 6.5 - Nature and contents of container
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors
  • Removal of Black Inverted Triangle

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 14 September 2023

File name

Emgality_PIL_EM032_Sep23_IE-NI-MT.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Removal of Black Inverted Triangle
  • Correction of spelling/typing errors

EDM Updated on 09 November 2022

File name

Emgality_pen_IFU_EM028_Oct22_IE-NI-MT.pdf

Reasons for updating

  • Replace File

Updated on 09 November 2022

File name

Emgality_PIL_EM027_Oct22_IE-NI-MT.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Improved presentation of PIL
  • Change to date of revision

Updated on 22 July 2022

File name

Emgality_SmPC_EM022_Jul22_IE-MT-NI.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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 22 July 2022

File name

Emgality_PIL_EM021_Jul22_IE-NI-MT.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

EDM Updated on 03 May 2022

File name

Emgality_pen_IFU_IE-NI-MT_Jul21.pdf

Reasons for updating

  • Add New Doc

Updated on 03 May 2022

File name

Emgality_IE NI MT_SmPC_EM012.pdf

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 03 May 2022

File name

PIL_Emgality_Pen_IE-NI-MT.pdf

Reasons for updating

  • New PIL for new product

Eli Lilly and Company (Ireland) Limited

Eli Lilly and Company (Ireland) Limited