PNEUMOVAX 23 solution for injection in pre-filled syringe

  • Name:

    PNEUMOVAX 23 solution for injection in pre-filled syringe

  • Company:
    info
  • Active Ingredients:

    Pneumococcal polysaccharide 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: 11/12/19

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Summary of Product Characteristics last updated on medicines.ie: 20/1/2020

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MSD Ireland (Human Health) Limited

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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 20 January 2020 SmPC

Reasons for updating

  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • 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 9: Added renewal date

Updated on 11 December 2019 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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

SPC change details:

  • End of section 4.4: Added heading on “Traceability”
  • Sections 4.5 and 5.1: Added text regarding concomitant administration of Pneumovax with Zostavax

Updated on 11 December 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 17 October 2019 PIL

Reasons for updating

  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Change to date of revision

Updated on 15 October 2019 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • 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

Sections 2 and 4.4: Added text on Excipient(s) with known effect (Sodium less than 1 mmol (23 mg) per dosage unit)

Section 5.1: Amended Pharmacotherapeutic group and ATC code

 

Updated on 15 October 2019 PIL

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - manufacturer

Free text change information supplied by the pharmaceutical company

Section 2 excipient warnings; Section 6 manufacturer

 

Updated on 17 June 2019 SmPC

Reasons for updating

  • Improved presentation of SmPC

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

Free text change information supplied by the pharmaceutical company

Converted the SPC from word format to pdf file format

 

Updated on 15 May 2018 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • 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 4.1: Abbreviated text with request to refer to section 5.1 for information on protection against specific pneumococcal serotypes
  • Section 4.2: Added text “The immunisation schedules for PNEUMOVAX 23 should be based on official recommendations.”
  • Section 5.1: Added text “The following pneumococcal capsular polysaccharides are included: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, 33F.”

Updated on 1 February 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 1 February 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 1 February 2018 SmPC

Reasons for updating

  • 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)

Free text change information supplied by the pharmaceutical company

Section 6.5: addition of “isoprene bromobutyl blend-polyisoprene” tip cap type

Updated on 1 February 2018 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Updated on 6 July 2017 SmPC

Reasons for updating

  • New SPC for new product

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 26 June 2017 PIL

Reasons for updating

  • New PIL for new product