Prevymis 240 mg concentrate for solution for infusion
*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 04 December 2023
File name
QRD-IE-UKNI-Prevymis-IV-LFT-II-033G.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 6 - date of revision
- Change to information for healthcare professionals
- Change to MA holder contact details
- Change to improve clarity and readability
Free text change information supplied by the pharmaceutical company
Updates following approval of the approval of II/0033/G (Extension of indication (KT/P002) + update to posology (HSCT/P040).
Updated on 30 November 2023
File name
PREVYMIS-H-C-4536-II-033-G-PI-en-IE-CRT IV Nov 2023 (clean).pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.2 - Incompatibilities
- 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
Updates following approval of the approval of II/0033/G (Extension of indication (KT/P002) + update to posology (HSCT/P040).
Updated on 03 July 2023
File name
QRD-IE-UKNI-Prevymis-IV-LFT-IG1623-062023.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Updates following approval of IG/1623 - Type IAIN Addition of MSD B.V. (Haarlem) as an additional batch release site.
Updated on 12 December 2022
File name
PREVYMIS-H-C-4536-IB-030-PI-en-IE-CRT IV Nov 2022 (clean).pdf
Reasons for updating
- Change to section 6.3 - Shelf life
- 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
Updates following approval of IB/0030 - Extension of shelf life from 30 months to 36 months for Prevymis IV.
Updated on 30 November 2022
File name
QRD-IE-UKNI-PREVYMIS-IV-LFT-IAin-XXX-Heist name change (Final).pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Updates following approval of IAIN-0031 to change the legal entity name of the batch release site located at Heist-op-den-Berg, Belgium from 'Schering-Plough Labo nv' to 'Organon Heist bv'.
Updated on 22 September 2022
File name
QRD-IE-UKNI-PREVYMIS-IV-LFT-R-027-RENEWAL 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 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
- Change to information for healthcare professionals
- Removal of Black Inverted Triangle
- Change to warnings or special precautions for use
Free text change information supplied by the pharmaceutical company
Updates following approval of the Renewal for Prevymis.
Updated on 21 September 2022
File name
PREVYMIS-H-C-4536-R-027-PI-en-IE-CRT IV Aug 2022 (clean).pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.2 - Incompatibilities
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updates following approval of the Renewal for Prevymis.
Updated on 31 May 2022
File name
QRD-IE-UKNI-PREMYVIS IV-LFT-BRX-NIP clean FT 20Apr22.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to other sources of information section
Free text change information supplied by the pharmaceutical company
Addition of United Kingdom (Northern Ireland) details to section 4 and section 6 of the PIL.
Updated on 31 January 2022
File name
PREVYMIS-H-C-4536-IB-024 IV PIL QRD IE.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 25 January 2022
File name
PREVYMIS-H-C-4536-IB-024-PI-en-IE-CRT IV Jan 2022 (clean).pdf
Reasons for updating
- 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
Updates to section 4.4, 5.1 and 10 following approval of PREVYMIS-IB/024 (QRD 10.2 + editorial changes).
Updated on 25 January 2021
File name
PREVYMIS-H-C-4536-IB019 IV PIL QRD IE (002).pdf
Reasons for updating
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
Updated on 19 January 2021
File name
PREVYMIS-H-C-4536-II-016 IV PIL QRD IE (002).pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
New PIL for new product
Updated on 19 January 2021
File name
PREVYMIS-H-C-4536-II-016-G-PI-en-IE-CRT IV Jul 2020 (clean) (002).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 SmPC for new product