ELIGARD 22.5 mg powder and solvent for solution for injection *
Pharmacy Only: Prescription

  • Company:

    Recordati 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

Updated on 23 November 2022

File name

637e2b5701721.pdf

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to information for healthcare professionals

Free text change information supplied by the pharmaceutical company

Updates for new administration device

Updated on 23 November 2022

File name

637e2acb41bb8.pdf

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling

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

Free text change information supplied by the pharmaceutical company

SmPC sections 6.5 and 6.6 updated with details of new administration device

Updated on 29 August 2022

File name

630c752b5ec87.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

section 2 - warnings and precautions - add a warning on Idiopathic intracranial hypertension

section 4 - amend the adverse reaction Idiopathic intracranial hypertension with a frequency of ‘Not known’

Updated on 29 August 2022

File name

630c742c84360.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

section 4.4 - add a warning on Idiopathic intracranial hypertension

section 4.8 - amend the adverse reaction Idiopathic intracranial hypertension to a frequency of ‘Not known’

Updated on 03 August 2021

File name

Eligard 22.5mg_IE_SmPC_1628003090.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 August 2021

File name

Eligard 22.5mg_IE_PIL_1628003011.pdf

Reasons for updating

  • New PIL for new product