TECVAYLI 10 mg/mL solution for injection
*Company:
Janssen Sciences IrelandStatus:
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 27 June 2024
File name
Tecvayli SmPC - NI and IE - MajesTEC1.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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
Change to section 4.2 - Posology and method of administration
Refer to Tables 9, 10 and 11 to determine the dosage based on predetermined weight ranges (see section 6.6).
Update Table 2
Change to section 4.8 - Undesirable effects
Addition of very common and common side effects
Change to section 5.1 - Pharmacodynamic properties
Addition of following information: "Results of an updated efficacy analysis after a median follow-up of 30.6 months among responders (n=104) showed a higher proportion of patients with CR (7.3%) and sCR (38.8%) compared with the primary analysis. MRD negativity rates also increased in all treated patients (29.1%) and in patients achieving CR or sCR (51.3%). The median DOR was 24.0 (17.0, NE) months. "
Updated on 27 June 2024
File name
Tecvayli PIL - NI and IE - MajesTEC1.pdf
Reasons for updating
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Addition of following side effects:
Very common:
- urinary tract infection,
- stomach pain (abdominal pain),
- muscle spasms,
- low blood pressure (hypotension) ·
Common:
- low level of sugar in the blood (hypoglycaemia)
Updated on 06 June 2024
File name
EN-Tecvayli-20240528-IE PIL-IB-013-clean-approved_EDMS-RIM-378075_40.0.pdf
Reasons for updating
- Change to section 6 - manufacturer
Free text change information supplied by the pharmaceutical company
EMA/H/C/5864/IB/013G: Addition of Beerse as a batch release site.
Updated on 06 June 2024
File name
EN-Tecvayli-20240528-IE-SmPC-IB-013-clean-approved_EDMS-RIM-378075_40.0.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
EMA/H/C/5864/IB/013G:
6.3 Shelf life
Unopened vial
18 months2 years
File name
Tecvayli Patient Card_EM-148252_Feb 2024.pdf
Reasons for updating
- Add New Doc
Free text change information supplied by the pharmaceutical company
Updated to inform and explain to patients the risks of CRS and nervous system toxicity, including ICANS.
Updated on 13 December 2023
File name
EN-Tecvayli-20231207-ICANs Update -clean-approved_SmPC.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 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 13 December 2023
File name
EN-Tecvayli-20231207-ICANs Update -clean-approved_PIL.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to information for healthcare professionals
Updated on 21 August 2023
File name
IE and NI - EN-Tecvayli-Patient Information Leaflet - Biweekly Dosing.pdf
Reasons for updating
- Change to section 3 - dose and frequency
Free text change information supplied by the pharmaceutical company
Tecvayli Posology update Q2W dosing.
Updated on 21 August 2023
File name
IE and NI - EN-Tecvayli-SmPC - Biweekly Dosing.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Tecvayli Posology update Q2W dosing.
File name
Tecvayli Patient Card_EM-128613_April 2023.pdf
Reasons for updating
- Add New Doc
Updated on 28 July 2023
File name
Tecvayli IE SPC_22.06.2023.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 28 July 2023
File name
Tecvayl_IE PIL_22 June 2023.pdf
Reasons for updating
- New PIL for new product