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TicoVac 0.5 ml Suspension for injection in a prefilled syringe

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Pharmacy Only: Prescription

Updated on 21 November 2024

File name

Reg PIL TI 18_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 8_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 10 April 2024

File name

Reg PIL TI 16 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 6_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 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 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 15_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 14_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 13_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 12_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 08 January 2019

File name

m-1-3-1-leaflet-0.5mg-clean.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 07 December 2018

File name

REG PIL TI 9_0 UK IE-clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 07 December 2018

File name

m1-3-2-spc-adult-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 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 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 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 07 September 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 07 September 2017

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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

addition to section 4.2 of the SPC of a 'catch-up' dose in individuals whose vaccination intervals were longer than recommended, and to include information on the clinical study supporting this update in section 5.1

Updated on 14 July 2017

File name

PIL_16302_238.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
  • 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 - 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 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

Update to Section 4.4, remove reference to latex; Sections 6.5 and 6.6 to update the nature and contents of the packs and the handling instructions.

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

None provided

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