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Trodelvy 200 mg powder for concentrate for solution for infusion

*
Pharmacy Only: Prescription

  • Company:

    Gilead Sciences Ltd

  • Status:

    No Recent Update

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

  • Active Ingredient(s):

    Sacituzumab Govitecan

    This medicinal product is subject to additional monitoring.

    *Additional information is available within the SPC or upon request to the company

Updated on 04 August 2023

File name

Trodelvy IE&XI SmPC (July 2023).pdf

Reasons for updating

  • 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 6.6 - Special precautions for disposal and other handling

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 04 August 2023

File name

Trodelvy IE&XI PIL (July 2023).pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 01 March 2023

File name

Trodelvy IE&XI PIL (Feb 2023).pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 01 March 2023

File name

Trodelvy IE&XI SmPC (Feb 2023).pdf

Reasons for updating

  • 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 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 18 July 2022

File name

Trodelvy IE&XI PIL (July 2022).pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 18 July 2022

File name

Trodelvy IE&XI SmPC (July 2022).pdf

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 25 November 2021

File name

Trodelvy SmPC XI&IE (November 2021).pdf

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 25 November 2021

File name

Trodelvy PIL XI&IE (November 2021).pdf

Reasons for updating

  • New PIL for new product