ELIGARD 7.5 mg powder and solvent for solution for injection

*
Pharmacy Only: Prescription
  • Company:

    Recordati Ireland Limited
  • Status:

    No Recent Update
  • 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

IE_Eligard_7.5mg_PIL.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

Update to administration device

Updated on 23 November 2022

File name

IE_Eligard_7.5mg_SmPC.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 are updated with details of the new administration device

Updated on 29 August 2022

File name

IE_Eligard_7.5mg_PIL.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

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

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

Updated on 29 August 2022

File name

IE_Eligard_7.5mg_SmPC.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 with a frequency of ‘Not known’

Updated on 03 August 2021

File name

Eligard 7.5mg_IE_PIL.pdf

Reasons for updating

  • New PIL for new product

Free text change information supplied by the pharmaceutical company

New PIL due to MA transfer

Updated on 03 August 2021

File name

Eligard 7.5mg_IE_SmPC.pdf

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

New SmPC due to MA transfer