ELIGARD 22.5 mg powder and solvent for solution for injection * Pharmacy Only: Prescription
Company:
Recordati Ireland LimitedStatus:
UpdatedLegal 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