TECVAYLI 90 mg/mL solution for injection

*
Pharmacy Only: Prescription
  • Company:

    Janssen Sciences Ireland
  • Status:

    No Recent Update
  • Legal 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

EDM Updated on 20 February 2024

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.

EDM Updated on 20 February 2024

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 19 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)

Free text change information supplied by the pharmaceutical company

ICANs Update

Updated on 19 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

Free text change information supplied by the pharmaceutical company

ICANs Update

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.

EDM Updated on 28 July 2023

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