TALVEY 40 mg/mL solution for injection
*Company:
Janssen Sciences Ireland (a Johnson & Johnson Company)Status:
UpdatedLegal 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 12 November 2025
File name
EN-IE-Talvey-20251016-PIL-VR-280497-clean-approved.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - what the product contains
- Change to information for healthcare professionals
Free text change information supplied by the pharmaceutical company
EMA/VR/0000280497 Type II variation – Update of section 5.1 of the SmPC in order to update immunogenicity data based on an updated Integrated Summary of Immunogenicity. In addition, the opportunity was taken to update the excipient information and warning regarding polysorbate and introduce editorial changes to the EUPI.
Updated on 12 November 2025
File name
EN-IE-Talvey-20251016-SmPC-VR-280497-clean-approved.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 6.1 - List of excipients
- 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
EMA/VR/0000280497 Type II variation – Update of section 5.1 of the SmPC in order to update immunogenicity data based on an updated Integrated Summary of Immunogenicity. In addition, the opportunity was taken to update the excipient information and warning regarding polysorbate and introduce editorial changes to the EUPI.
File name
TALVEY HCP Educational Guide-31.10.2025.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
HCP educational guide updated to be rebranded and update the company adverse reporting phone number.
File name
TALVEY Patient Card-31.10.2025.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Card updated to be rebranded and update the company adverse reporting phone number.
Updated on 16 October 2025
File name
EN-Talvey-20250926-PIL-VR-0000286343-clean-approved.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
EMA/VR/0000258454 - Type II – Ataxia disorder, Removal of local representative details for Northern Ireland.
EMA/VR/0000286343 - Type IB - update E numbers.
Updated on 16 October 2025
File name
EN-Talvey-20250926-SPC-VR-0000286343-clean-approved.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 6.1 - List of excipients
- 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
EMA/VR/0000258454 - Type II – Ataxia disorder
EMA/VR/0000286343 - Type IB - Shelf life extension from 2 to 3 years, update E numbers
Updated on 11 June 2025
File name
EN-Talvey-20250602-SmPC-EU PSUR 02-PSUSA-99-202408-Clean-approved.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- 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
PSUR: procedure (EMEA/H/C/PSUSA/00000099/202408): Submission of EU PSUR 02 (9 Feb 2024 to 8 Aug 2024)
Updated on 11 June 2025
File name
EN-Talvey-20250602-PIL-EU PSUR 02-PSUSA-99-202408-Clean-approved.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
PSUR: procedure (EMEA/H/C/PSUSA/00000099/202408): Submission of EU PSUR 02 (9 Feb 2024 to 8 Aug 2024)
Updated on 11 June 2025
File name
EN-Talvey-20250602-SmPC-EU PSUR 02-PSUSA-99-202408-Clean-approved.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
PSUR: procedure (EMEA/H/C/PSUSA/00000099/202408): Submission of EU PSUR 02 (9 Feb 2024 to 8 Aug 2024)
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
- Addition of 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 ATC code.
Also editorial changes have been made to the SPC.
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 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)
Updated on 18 April 2024
File name
EN-Talvey-MAA-clean-approved_PIL.pdf
Reasons for updating
- New PIL for new product
Janssen Sciences Ireland (a Johnson & Johnson Company)
Address:
Janssen Sciences Ireland UC, Barnahely, Ringaskiddy, IRL - Co. Cork P43 FA46Medical Information E-mail:
medinfo@its.jnj.comTelephone:
+353 1 4665200Website:
https://innovativemedicine.jnj.com/ireland/Medical Information Direct Line:
1800 709 122