Vaxneuvance suspension 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):
This medicinal product is subject to additional monitoring.
*Additional information is available within the SPC or upon request to the company
Updated on 23 November 2023
File name
VAXNEUVANCE-H-C-5477-IB0018-SPC-IE-en-CRT.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Shelf life extension from 30 months to 3 years and updates to tip cap in section 6.5.
Updated on 11 May 2023
File name
VAXNEUVANCE-H-C-5477-II011-II013-G-SPC-IE-en April 2023.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - 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
Updates from clinical study on Vaxneuvance in Recipients of Allogeneic Hematopoietic Stem Cell Transplant; updates from clinical study on 3-dose Regimen of Vaxneuvance in Healthy Infants.
Updated on 11 May 2023
File name
QRD-IE-MT-UKNI-VAXNEUVANCE-LFT-II-011-II-013G 26042023.pdf
Reasons for updating
- Change to section 3 - use in children/adolescents
- Change to information for healthcare professionals
Updated on 09 November 2022
File name
VAXNEUVANCE-H-C-5477-II001-SPC-IE-en Oct 2022.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
New paediatric indication.
Updated on 09 November 2022
File name
QRD-IE-MT-UKNI-VAXNEUVANCE-LFT-II-001 21102022.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 4 - possible side effects
- Change to information for healthcare professionals
- Change to warnings or special precautions for use
- Change to dosage and administration
Updated on 17 October 2022
File name
VAXNEUVANCE-H-C-5477-IB008-SPC-IE-en Sep 2022.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Shelf-life extension to 30 months.
Updated on 30 August 2022
File name
VAXNEUVANCE-H-C-5477-IB003-SPC-IE-en April 2022.pdf
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
New SPC for new product.
Updated on 30 August 2022
File name
QRD-IE-MT-UKNI-VAXNEUVANCE-LFT-OMA-IB-003 27042022.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
New PIL for new product.