Gardasil 9 suspension for injection in a pre-filled syringe

  • Name:

    Gardasil 9 suspension for injection in a pre-filled syringe

  • Company:
    info
  • Active Ingredients:

    Human papillomavirus 9-valent vaccine

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 10/06/19

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Summary of Product Characteristics last updated on medicines.ie: 22/5/2019
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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MSD Ireland (Human Health) Limited

MSD Ireland (Human Health) Limited

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1 - 0 of 84 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 10 June 2019 PIL

Reasons for updating

  • Change to other sources of information section

Updated on 22 May 2019 PIL

Reasons for updating

  • Change to other sources of information section

Updated on 22 May 2019 SmPC

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 SmPC

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 7 September 2018 SmPC

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 PIL

Reasons for updating

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

Updated on 6 December 2017 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 6 December 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 24 July 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 21 July 2017 PIL

Reasons for updating

  • New PIL for medicines.ie