PNEUMOVAX 23 solution for injection in pre-filled syringe
- Name:
PNEUMOVAX 23 solution for injection in pre-filled syringe
- Company:
MSD Ireland (Human Health) Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 30/07/20
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MSD Ireland (Human Health) Limited
Company Products
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 30 July 2020 PIL
Reasons for updating
- Addition of marketing authorisation holder
- Addition of information on reporting a side effect.
Free text change information supplied by the pharmaceutical company
Addition of local details for Malta
Updated on 20 January 2020 SPC
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 SPC
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 SPC
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 SPC
Reasons for updating
- Improved presentation of SPC
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 SPC
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 SPC
Reasons for updating
- New SPC 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 SPC
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
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 SPC
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
Updated on 26 June 2017 PIL
Reasons for updating
- New PIL for new product