TicoVac Junior 0.25 ml Suspension for injection in a pre-filled syringe
*Company:
Pfizer Healthcare Ireland Unlimited CompanyStatus:
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 21 November 2024
File name
Reg PIL TI Junior 19_1 IE-clean.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 3 - duration of treatment
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
- Change to other sources of information section
Free text change information supplied by the pharmaceutical company
The PIL has been updated to reflect the SPC changes.
Updated on 21 November 2024
File name
Reg SPC TI Junior 9_1 IE-clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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 5.1 - Pharmacodynamic properties
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Updates to sections 4.2, and 6.5 and editorial updates to section 4.4, 4.8, and 5.1
Updated on 19 November 2024
File name
Reg SPC TI Junior 8_0 IE-clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 19 November 2024
File name
Reg PIL TI Junior 18_0 IE-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 10 April 2024
File name
Reg PIL TI Junior 17 0 IE clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 14 February 2023
File name
DEC202154145_Reg SPC TI Junior 7_1 IE clean.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 11 August 2021
File name
DEC202154145_Reg SPC TI Junior 7_1 IE clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.5 - Nature and contents of container
- 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 11 August 2021
File name
DEC202154145_Reg PIL TI Junior 16_1 IE clean.pdf
Reasons for updating
- Change to section 3 - dose and frequency
- Change to section 6 - what the product looks like and pack contents
- Change to other sources of information section
- Correction of spelling/typing errors
Updated on 10 March 2021
File name
DEC202116557_Reg PIL TI Junior 15_0 IE clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
Updated on 18 February 2021
File name
DEC202110833_Reg PIL TI Junior 14_1 IE (clean).pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 08 June 2020
File name
DEC202037523_Reg PIL TI Junior 13_2 UK IE clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 15 April 2019
File name
Reg PIL TI Junior 11_1 UK IE-clean.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 31 January 2019
File name
REG PIL TI Junior 10_0 UK IE-clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 31 January 2019
File name
Reg SPC TI Junior 6_1 IE-clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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
The SPC The SPC has been updated as follows:
Section 4.2 - Method of administration; Section 4.4; Section 4.8; Section 6.5; Section 6.6
Updated on 10 August 2018
File name
Reg PIL TI Junior 7_1 UK IE clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
- Change to name of medicinal product
Updated on 18 July 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 18 July 2017
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)
Free text change information supplied by the pharmaceutical company
The SPC has been updated:
NB - Only TicoVac Junior 0.25ml solution for injection in a pre-filled syringe is impacted.
Section 4.8. adverse drug reaction information in relation to Guilain-Barre Syndrome (GBS).
Updated on 14 July 2017
File name
PIL_16303_73.pdf
Reasons for updating
- New PIL for new product
Updated on 14 July 2017
Reasons for updating
- 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 4.3 - Contraindications
- Change to section 4.6 - Pregnancy and lactation
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.2 - Incompatibilities
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Section 2, 4.2, 4.3, 4.6, 4.8, 5.1, 6.2 and 6.5.
Updated on 08 March 2017
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 3 - dose and frequency
- Change to section 3 - duration of treatment
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Updated on 08 February 2017
Reasons for updating
- Change to section 4.2 - Posology and method of administration
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The following changes to the labelling have been approved. Please refer to attached copy/copies of labelling documentation for full details.
Updated on 03 February 2017
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 3 - duration of treatment
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Updated on 14 September 2016
Reasons for updating
- Addition of information on reporting a side effect.
Updated on 04 August 2016
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
Updated on 02 August 2016
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to further information section
- Change to date of revision
Updated on 08 May 2015
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 05 May 2015
Reasons for updating
- New PIL for medicines.ie
Updated on 05 May 2015
Reasons for updating
- Change of manufacturer
- Change to date of revision