Sunlenca 464 mg 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):

    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 05 March 2025

File name

Sunlenca Injection Ireland SmPC (January 2025).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 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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)

Updated on 05 March 2025

File name

Sunlenca Injection Ireland PIL (January 2025).pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Change to section 7 - Instructions for use

Updated on 22 October 2024

File name

Sunlenca Injection IE-XI SmPC (Sept 2024).pdf

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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 28 August 2024

File name

Sunlenca Injection IE-XI PIL (July 2024).pdf

Reasons for updating

  • Correction of spelling/typing errors

Updated on 28 August 2024

File name

Sunlenca Injection IE-XI SmPC (July 2024).pdf

Reasons for updating

  • Change to section 5.3 - Preclinical safety data

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

Updated on 30 June 2023

File name

Sunlenca - Injection - IE-XI PIL (June 2023).pdf

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility

Updated on 30 June 2023

File name

Sunlenca - Injection - IE-XI SmPC (June 2023).pdf

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 6.3 - Shelf life

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

Updated on 21 October 2022

File name

Sunlenca - Injection - IE-XI SmPC (August 2022) - updated.pdf

Reasons for updating

  • New SPC for new product

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

Updated on 21 October 2022

File name

Sunlenca - Injection - IE-XI PIL (August 2022) - updated.pdf

Reasons for updating

  • New PIL for new product

Gilead Sciences Ltd

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