Gardasil 9 suspension for injection in a pre-filled syringe
*Company:
MSD Ireland (Human Health) LimitedStatus:
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 12 April 2024
File name
GARDASIL9-H-C-3852-II-069-SPC-IE-en-CRT.pdf
Reasons for updating
- 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 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 5.1 of SmPC updated based on the result from 4th Interim Report for Study V503-021, minor updates to section 4.8 and 6.1 and updated date of revision.
Updated on 05 April 2024
File name
QRD-IE-MT-UKNI-GARDASIL9-LFT-II-069-26032024.pdf
Reasons for updating
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Email address update for the local representative of the Marketing Authorisation Holder in Ireland.
Updated on 06 July 2023
File name
GARDASIL9-H-C-3852-II-063-SPC-IE-en-CRT-May 2023.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- 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 section 4.6 following EMEA/H/C/003852/II/0063.
Updated on 06 July 2023
File name
QRD IE-MT-UKNI-GARDASIL 9-LFT-RCN024757 RCN025177 CRT FT27Jun23.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 13 April 2023
File name
GARDASIL9-H-C-3852-PSUSA-202206-SPC-IE-en-CRT-Mar 2023.pdf
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
SPC update to section 4.8 following PSUSA/00010389/202206.
Updated on 21 November 2022
File name
GARDASIL9-H-C-3852-WS-2336-SPC-IE-en-CRT- Oct 2022.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- 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 5.1 was updated to add the effect of vaccination campaigns on the reduction in the incidence of Juvenile-onset Recurrent Respiratory Papillomatosis (JoRRP).
Updated on 23 May 2022
File name
GARDASIL9-H-C-3852-T-054-II-053-SPC-IE-en-April 2022_CRT.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
QRD-IE-MT-UKNI-PRODUCT-LFT-BRX-NIP-MAT- FT 10-May-2022.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.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.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.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.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).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.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.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.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.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.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.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.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).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