ELIGARD 45 mg powder and solvent for solution for injection
*Company:
Recordati Ireland 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 23 November 2022
File name
IE_Eligard_45mg_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
Updates for new administration device
Updated on 23 November 2022
File name
IE_Eligard_45mg_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 updated with details of new administration device
Updated on 29 August 2022
File name
IE_Eligard_45mg_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 2 - warnings and precautions - add a warning on Idiopathic intracranial hypertension
section 4 - possible side effects - amend the adverse reaction Idiopathic intracranial hypertension to a frequency of ‘Not known’
Updated on 29 August 2022
File name
IE_Eligard_45mg_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
Eligard 45mg_IE_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 to a frequency of ‘Not known’
Updated on 03 August 2021
File name
Eligard 45mg_IE_PIL.pdf
Reasons for updating
- New PIL for new product
Updated on 03 August 2021
File name
Eligard 45mg_IE_SmPC.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)