Rotarix oral suspension in pre-filled oral applicator * Pharmacy Only: Prescription
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 20 January 2022
File name
ieukni-spc-combined-rotarixOSrange-issue10draft1-Master_1642678148.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-rotarixoralapplicator-issue11draft1-Master_1642678065.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-rotarixoralapplicator-issue10draft1-clean_1634742880.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 19 February 2020
File name
ie-pil-rotarixoralapplicator-issue9draft1-medsie_1582108756.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
- Change to MA holder contact details
- Correction of spelling/typing errors
Free text change information supplied by the pharmaceutical company
HPRA AE reporting details updated.
Some countries have updated information in local representative of the Marketing Authorisation Holder section
QRD 10.1 updates
Updated on 19 February 2020
File name
ie-spc-rotarixOSrange-issue9draft1-medsie_1582106514.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
4.4 Special warnings and precautions for use - tracability information has been provided
4.8 Undesirable effects - HPRA AE details updated
Updated on 02 April 2019
File name
ie-pil-rotarixoralapplicator-issue8draft1-medsie_1554215119.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
Updated on 02 April 2019
File name
ie-spc-rotarixOSrange-issue8draft1-medsie_1554215061.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 of the SmPC of Rotarix includes a warning on administration of Rotarix to infants who have known or suspected immunodeficiency
Section 4.8 - addition of Urticaria
Updated on 08 August 2018
File name
ie-spc-rotarix-medsie_1533732163.pdf
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Typo corrected for multi-monodose MA number.
Updated on 07 August 2018
File name
ie-pil-rotarixoralapplicator-issue7draft1-medsie_1533559075.pdf
Reasons for updating
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Updated on 06 August 2018
File name
ie-spc-rotarix-medsie_1533558913.pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.3 - Shelf life
- 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 8 - Marketing authorisation number(s)
- 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
1. NAME OF THE MEDICINAL PRODUCT - combined SPC. Now contains pre-filled oral applicator, squeezable tube and new presentation which is the multi-monodose (5 single dose) squeezable tube presentation connected by a bar
5.1 Pharmacodynamic properties - minor formatting changes
6.3 Shelf life - - Pre-filled oral applicator: 3 years.
- Squeezable tube fitted with a membrane and a tube cap: 3 years
- Multi-monodose (5 single dose) squeezable tube presentation connected by a bar: 2 years
6.5 Nature and contents of container - added in contents of container for squeezable tube and new presentation which is the multi-monodose (5 single dose) squeezable tube presentation connected by a bar
6.6 Special precautions for disposal and other handling - Instructions for administration of the vaccine in a squeezable tube and instructions for administration of the vaccine in a multi-monodose (5 single dose) squeezable tube presentation connected by a bar have been added in.
8. MARKETING AUTHORISATION NUMBER(S) - squeezable tube and multi-monodose (5 single dose) squeezable tube MA numbers added in.
Updated on 01 June 2018
File name
ie-spc-rotarixoralapplicator.docx
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 11 May 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 30 April 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 28 April 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 28 April 2017
Reasons for updating
- 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
Updated on 27 April 2017
File name
PIL_15019_827.pdf
Reasons for updating
- New PIL for new product
Updated on 27 April 2017
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
Updated on 10 March 2017
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
- Improved presentation of SPC
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 2: Addition of a comma so that "1073 mg" now reads "1,073 mg"
Section 4.2: "For instructions for the preparation or reconstitution of the medicinal product before administration, see section 6.6." changed to "For instructions for administration, see section 6.6."
Section 4.8: Insertion of commas between the third and fourth digit of numbers, other minor typographical corrections.
Section 5.1: New sub-heading and paragraph on vaccine effectiveness. New information added to the "Effectiveness after 2 doses in preventing RVGE leading to hospitalization" Table. Impact on mortality and impact on hospitalisation paragraphs updated. Insertion of commas between the third and fourth digit of numbers, other minor typographical corrections.
Section 9: Date of last renewal updated
Updated on 25 January 2016
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 9 - Date of renewal of 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
Minor editorial updates to SPC sections 2, 4.2, 4.8, 5.1, and 6.6
Section 9 – renewal date update.
Updated on 25 January 2016
Reasons for updating
- Change to date of revision
- Change to MA holder contact details
- Addition of information on reporting a side effect.
Updated on 01 October 2015
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 4.9 - Overdose
- 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 section 4.8 of the SPC with HPRA reporting details
Update section 4.9 of the SPC re overdosage.
Updated on 27 June 2014
Reasons for updating
- Change to section 10 - Date of revision of the text
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
4.4 Special warnings and precautions for use
Updated warning statements regarding intussusception reflecting data from observational safety studies, which indicate an increased risk of intussusceptions, mostly within 7 days after rotavirus vaccination.
4.8 Undesirable effects
- Revised list of adverse reactions to tabulated format.
- Updated the frequency of intussusception from previously not defined to ‘very rare’
- Updated the instructions regarding the reporting of adverse events to the IMB
Updated on 26 June 2014
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 08 October 2013
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.8 - Undesirable effects,
Section 5.1 - Pharmacodynamic properties
Updated on 08 October 2013
Reasons for updating
- Change to side-effects
Updated on 17 May 2013
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 03 May 2013
Reasons for updating
- Improved electronic presentation
Updated on 19 January 2012
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 20 June 2011
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 20 June 2011
Reasons for updating
- New PIL for new product