Rotarix oral suspension in squeezable tube
*Company:
GlaxoSmithKline (Ireland) LtdStatus:
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 09 August 2024
File name
ie-spc-combined-rotarixOSrange-issue12draft1-clean-no headers.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 09 August 2024
File name
ie-pil-combined-rotarixtube-issue5draft1-clean-no headers.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
Updated on 07 August 2023
File name
ieukni-spc-combined-rotarixOSrange-issue11draft1-clean.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- 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
Update to SPC section 2 and 4.4 to correct the sodium content dosage from 34mg to 32mg.
Updated on 07 August 2023
File name
ieukni-pil-combined-rotarixtube-issue4draft1-clean.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - date of revision
Updated on 20 January 2022
File name
ieukni-spc-combined-rotarixOSrange-issue10draft1-Master.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.1 - List of excipients
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 January 2022
File name
ieukni-pil-combined-rotarixtube-issue3draft1-Master.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - date of revision
Updated on 20 October 2021
File name
ieukni-pil-combined-rotarixtube-issue2draft1-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
- Change to MA holder contact details
Updated on 20 October 2021
File name
ieukni-pil-combined-rotarixoralapplicator-issue10draft1-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
- Change to MA holder contact details
Updated on 16 July 2021
File name
ie-pil-rotarixtube-issue1draft1-medsie.pdf
Reasons for updating
- New PIL for new product
Updated on 16 July 2021
File name
ie-spc-rotarixOSrange-issue9draft1-medsie.pdf
Reasons for updating
- Other
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 14 July 2021
File name
ie-spc-rotarixtube-issue1draft1-medsie.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)