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HEPCLUDEX 2 mg powder for solution for injection

*
Pharmacy Only: Prescription

  • Company:

    Gilead Sciences Ltd

  • Status:

    Updated

  • Legal Category:

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

  • Active Ingredient(s):

    Bulevirtide

    This medicinal product is subject to additional monitoring.

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

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Updated on 23 March 2026

File name

Hepcludex Ireland SmPC (March 2026).pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

Grouped Type II variation to provide final CSR for Study MYR301 fulfilling the Category 3 Hepcludex EU-RMP milestone and propose the removal of study GS-US-589-6206 as a Category 3 commitment from the Hepcludex EU-RMP.

 


Updated on 03 March 2026

File name

Hepcludex Ireland PIL February 2026) - clean.pdf

Reasons for updating

  • Change to section 7 - Instructions for use

Free text change information supplied by the pharmaceutical company 

 Updated on 19 January 2026 
File name
Hepcludex Ireland PIL (January 2026).pdf
Reasons for updating
  •  Change to section 2 - what you need to know - contraindications 
  •  Change to section 5 - how to store or dispose   
  •  Change to section 7 - Instructions for use 
 Updated on 19 January 2026 
File name
Hepcludex Ireland SmPC January 2026).pdf
Reasons for updating
  •  Change to section 4.4 - Special warnings and precautions for use 
Legal category:Product subject to medical prescription which may not be renewed (A)
 Updated on 09 September 2025 
File name
Hepcludex Ireland SmPC (September 2025).pdf
Reasons for updating
  •  Change to section 6.3 - Shelf life  
Legal category:Product subject to medical prescription which may not be renewed (A)
 Updated on 17 December 2024 
File name
Hepcludex IE& XI SmPC (November 2024).pdf
Reasons for updating
  •  Change to section 4.1 - Therapeutic indications 
  •  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)
 Updated on 17 December 2024 
File name
Hepcludex IE& XI PIL (November 2024).pdf
Reasons for updating
  •  Change to section 1 - what the product is used for  
  •  Change to section 2 - use in children and adolescents   
  •  Change to section 3 - dose and frequency 
  •  Change to section 3 - use in children/adolescents   
 Updated on 07 November 2024 
File name
Hepcludex IE& XI SmPC (October 2024).pdf
Reasons for updating
  •  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 
EMEA/H/C/004854/II/0034
 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 
Gilead Sciences Ltd
Gilead Sciences Ltd