PNEUMOVAX 23 solution for injection in pre-filled syringe
*Company:
MSD Ireland (Human Health) LimitedStatus:
No Recent UpdateLegal 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 06 December 2022
File name
Pneumovax PFS-DE-H-4906-002-IAIN-0076-SPC-IE-en-CRT.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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 implement the PRAC adopted recommendation signal of Extensive swelling of vaccinated limb.
Updated on 06 December 2022
File name
QRD-IE-MT-Pneumovax23-PFS-LFT-IAIN-0076-en-CRT.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
- Change to other sources of information section
Free text change information supplied by the pharmaceutical company
Update to implement the PRAC adopted recommendation signal of Extensive swelling of vaccinated limb.
Updated on 09 February 2022
File name
QRD-IE-MT-Pneumovax23-PFS-LFT-Art-61.3-CRT.pdf
Reasons for updating
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Administrative - implementation alignment with Malta (shared leaflet).
Updated on 03 February 2022
File name
QRD-IE-MT-Pneumovax23-PFS-LFT-Art-61.3-CRT.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Change to formatting in heading of PIL.
Updated on 30 July 2020
File name
QRD_PNEUMOVAX PFS_PIL_MT joint packs.pdf
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
File name
PNEUMOVAX PFS-DE-H-4906-002-R-003-SPC-IE-en-CRT Jan 2020 (002).pdf
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
File name
PNEUMOVAX PFS-DE-H-4906-002-WS-064-SPC-IE-en Nov 2019 (002).pdf
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
File name
QRD_PNEUMOVAX_PFS_PIL_WS064 (002).pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 17 October 2019
File name
QRD_Pneumovax_PFS_PIL_IB063G (002).pdf
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
File name
PNEUMOVAX PFS-DE-H-4906-002-IG-0063-SPC-IE-en-Oct 2019 (002).pdf
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
File name
QRD_Pneumovax_PFS_PIL_IB063G_clean (002).pdf
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
File name
PNEUMOVAX PFS-UK-H-0399-003-IB-060-SPC-IE-en-CRT May 2018.pdf
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
File name
PNEUMOVAX_PFS_UK_H_0399_003_IB_060_G_SPC_IE_en_CRT.docx
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 01 February 2018
File name
PIL_17194_924.pdf
Reasons for updating
- New PIL for new product
Updated on 01 February 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 01 February 2018
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 01 February 2018
Reasons for updating
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Updated on 06 July 2017
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
Reasons for updating
- New PIL for new product