HEPCLUDEX 2 mg powder for solution for injection

  • Company:

    Gilead Sciences Ltd
  • 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

Updated on 26 July 2023

File name

Hepcludex IE & XI SmPC (July 2023).pdf

Reasons for updating

  • 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 26 July 2023

File name

Hepcludex IE & XI PIL (July 2023).pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 06 April 2023

File name

Hepcludex IE& XI SmPC (March 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 06 April 2023

File name

Hepcludex IE& XI PIL (March 2023).pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 23 August 2022

File name

Hepcludex IE& XI SmPC (July 2022).pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4 - Clinical particulars

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

Updated on 23 August 2022

File name

Hepcludex IE& XI PIL (July 2022).pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 14 July 2022

File name

Hepcludex SmPC IE&XI (June 2022).pdf

Reasons for updating

  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • 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 29 March 2022

File name

Hepcludex SmPC IE-XI (September 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 29 March 2022

File name

Hepcludex PIL IE-XI (November 2021).pdf

Reasons for updating

  • New PIL for new product