Rotarix oral suspension in squeezable tube
*Company:
GlaxoSmithKline (Ireland) LtdStatus:
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 03 August 2026
File name
ie-spc-combined-rotarixOSrange-issue14draft1-Master.pdf
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- 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 of section 6.5 “Nature and contents of container and section 6.6 “Special precautions for disposal and other handling” of the summary of product characteristics for sections pertaining to Rotarix oral suspension in pre-filled oral applicator only. No change to the tube presentation information in these sections.
Other editorial changes across SPC.
Updated on 03 August 2026
File name
ie-pil-combined-rotarixtube-issue7draft1-Master.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Change to to local representatives section - removal of United Kingdom (Northern Ireland)
Updated on 28 April 2026
File name
ie-spc-combined-rotarixOSrange-issue13draft1-clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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
PRAC recommendation: update of sections 4.4 and 4.8 of the SmPC to add a warning/precaution regarding anaphylactic reaction and to add the adverse reaction anaphylactic reaction with a frequency not known.
Updated on 28 April 2026
File name
ie-pil-combined-rotarixtube-issue6draft1-clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Section 4 of the PIL - to add the adverse reaction anaphylactic reaction
Updated on 11 March 2026
File name
ie-spc-combined-rotarixOSrange-issue12draft1-clean.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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
Reverted to previous version of the SPC. Updates: Removal of Northern Ireland reporting details due to Windsor Framework
Updated on 11 March 2026
File name
ie-pil-combined-rotarixtube-issue5draft1-clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Previous version of the PIL being reinstated. Changes to the PIL: Removal of Northern Ireland reporting of side effects details from section 4, as part of Windsor Framework
Updated on 03 March 2026
File name
ie-pil-combined-rotarixtube-issue6draft1-clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Section 4 of the PIL - to add the adverse reaction anaphylactic reaction
Updated on 03 March 2026
File name
ie-spc-combined-rotarixOSrange-issue13draft1-clean.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
PRAC recommendation: update of sections 4.4 and 4.8 of the SmPC to add a warning/precaution regarding anaphylactic reaction and to add the adverse reaction anaphylactic reaction with a frequency not known.
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)
GlaxoSmithKline (Ireland) Ltd
Address:
12 Riverwalk, Citywest Business Campus, Dublin 24, IrelandTelephone:
+353 1 495 5000Medical Information Direct Line:
1 800 244 255