Rukobia 600 mg prolonged-release tablets
*Company:
ViiV Healthcare BVStatus:
UpdatedLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
This medicinal product is subject to additional monitoring.
*Additional information is available within the SPC or upon request to the company
Updated on 15 September 2025
File name
ie-pl-combined-rukobia-issue6draft1-clean-no headers.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Changes following Renewal Application
Section 6 - What Rukobia looks like - deletion of 'film coated'
Minor administrative updates to addresses
Updated on 15 September 2025
File name
ie-spc-combined-rukobia-issue7draft1-clean-no headers.pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 4.8 - Undesirable effects
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- 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
Changes following Renewal Application -
Section 3 - deletion of 'film coated'
Section 4.8 - deletion of 'treatment emergent' and minor administrative amendments
Section 9 - addition of last renewal date
Section - Update of last revision date
Updated on 28 November 2024
File name
ie-spc-combined-rukobia-issue6draft1med.ie.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
Launch of Rukobia in Ireland
Updated on 28 November 2024
File name
ie-pl-combined-rukobia-issue5draft1 medie.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
Launch of Rukobia
ViiV Healthcare BV
Address:
12 Riverwalk, Citywest Business Campus, Dublin 24, IrelandTelephone:
+353 1 495 5000Medical Information Direct Line:
1 800 244 255