Gardasil 9 suspension for injection in a pre-filled syringe *
Pharmacy Only: Prescription

Updated on 23 May 2022

File name

628b84b0e0ece.pdf

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 7 - Marketing authorisation holder
  • 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 5.1 of the SmPC with the final results from the long-term follow-up (LTFU) Study and to update the marketing authorisation holder in section 7. 

Updated on 23 May 2022

File name

628b83f0a6bd1.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

Minor formatting changes have been implemented throughout the text.

Addition of United Kingdom(Northern Ireland) reporting and local representative details.

Update copyright statement.

Updated on 03 December 2021

File name

GARDASIL9-H-C-3852-IB-052-SPC-IE-en November 2021_1638540671.pdf

Reasons for updating

  • Change to section 6.4 - Special precautions for storage

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

Free text change information supplied by the pharmaceutical company

Amended storage conditions: “Stability data indicate that the vaccine components are stable for 96 hours when stored at temperatures from 8 °C to 40 °C or for 72 hours when stored at temperatures from 0 °C to 2 °C.”

Updated on 15 March 2021

File name

QRD_EN_GARDASIL 9_PIL_II-040_1615813745.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Updated on 15 March 2021

File name

GARDASIL9-H-C-3852-II-040-SPC-IE-en January 2021_1615813563.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

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: Addition of sodium content statement

Section 4.8: Updates from clinical trials, post marketing data

Updated on 21 May 2020

File name

GARDASIL9-H-C-3852-II-037-G-SPC-IE-en April 2020 (002).pdf_1590067613.pdf

Reasons for updating

  • 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 Pharmacodynamic properties (section 5.1)

 

Updated on 27 February 2020

File name

QRD_EN_GARDASIL 9_PIL_II-033-R-035 (002)_1582802346.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect

Free text change information supplied by the pharmaceutical company

Updated HPRA adverse event reporting    

Updated on 29 January 2020

File name

QRD_EN_GARDASIL 9_PIL_II-033-R-035_1580322512.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 6 - what the product contains
  • Removal of Black Inverted Triangle

Updated on 29 January 2020

File name

GARDASIL9-H-C-3852-II-033-R-035-SPC-IE-en Nov 2019_1580322159.pdf

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text
  • Removal of Black Inverted Triangle

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

Free text change information supplied by the pharmaceutical company

Removal of black inverted triangle; added "Traceability" heading in section 4.4; added details under "breast-feeding" (section 4.6); added text in section 4.8: "In a clinical trial that included 640 individuals aged 27 to 45 years and 570 individuals aged 16 to 26 years who received Gardasil 9, the safety profile of Gardasil 9 was comparable between the two age groups"

Updated on 10 June 2019

File name

QRD_EN_GARDASIL 9_PIL_IAIN_032_1560173190.pdf

Reasons for updating

  • Change to other sources of information section

Updated on 22 May 2019

File name

QRD_EN_GARDASIL 9_PIL_IAIN_032_1558534393.pdf

Reasons for updating

  • Change to other sources of information section

Updated on 22 May 2019

File name

GARDASIL9-H-C-3852-IAIN-032-SPC-IE-en Apr 2019_1558534626.pdf

Reasons for updating

  • 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)

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

Free text change information supplied by the pharmaceutical company

Change to Section 6.5, 6.6, 8.

New pack size (10-pack syringes without needles)

 

Updated on 27 February 2019

File name

GARDASIL9-H-C-3852-II-028G-SPC-IE-en Jan 2019_1551254022.pdf

Reasons for updating

  • 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

Updates to section 5.1

 

Updated on 07 September 2018

File name

GARDASIL9-H-C-3852-II-024-G-SPC-IE-en Jul 2018_1536316395.pdf

Reasons for updating

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

5.1: Updated long-term efficacy studies; new paragraph on Evidence of anamnestic (Immune Memory) response

Updated on 20 August 2018

File name

QRD_EN_GARDASIL 9_PIL_BRX_PRO (2)_1534766335.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to other sources of information section

Updated on 06 December 2017

File name

PIL_17225_541.pdf

Reasons for updating

  • New PIL for new product

Updated on 06 December 2017

Reasons for updating

  • Correction of spelling/typing errors

Updated on 24 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 21 July 2017

Reasons for updating

  • New PIL for medicines.ie