TALVEY 2 mg/mL solution for injection
*Company:
Janssen Sciences Ireland (a Johnson & Johnson Company)Status:
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 03 July 2024
File name
Patient Information Leaflet - NI and IE - Addition of Beerse as a Secondary Packaging Site - 28th June.pdf
Reasons for updating
- Change to section 6 - manufacturer
Free text change information supplied by the pharmaceutical company
Addition of Manufacturer in section 6:
Janssen Pharmaceutica NV
Turnhoutseweg 30
B-2340 Beerse
Belgium
Updated on 21 May 2024
File name
EN-Talvey-20240416-clean-approved_PIL.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
- Change to improve clarity and readability
Free text change information supplied by the pharmaceutical company
Section 2 has been updated to add the following text:
Fertility
There are no data on the effect of talquetamab on fertility. Effects of talquetamab on male and female fertility have not been evaluated in animal studies.
Editorial changes have also been made to the package leaflet.
Updated on 21 May 2024
File name
EN-Talvey-20240416-clean-approved SPC.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
- Change to improve clarity and readability
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 5.1 has been updated to add the ATC code.
Also editorial changes have been made to SPC.
Updated on 18 April 2024
File name
EN-Talvey SPC-20240312-shelf life update-clean-approved_SPC.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
File name
TALVEY_HCP Educational Guide_26.10.2023.pdf
Reasons for updating
- Add New Doc
File name
TALVEY_Patient Card_26.10.2023.pdf
Reasons for updating
- Add New Doc
Updated on 18 April 2024
File name
EN-Talvey-MAA-clean-approved_PIL.pdf
Reasons for updating
- New PIL for new product