Nucala 100 mg solution for injection in pre-filled pen

*
Pharmacy Only: Prescription
  • Company:

    GlaxoSmithKline (Ireland) Ltd
  • Status:

    Updated
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

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

Updated on 05 July 2024

File name

ieukni-spc-combined-nucala-liquid-issue8draft1.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)

Updated on 05 July 2024

File name

ieukni-pl-combined-nucala-pfp-issue10draft1.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 21 October 2022

File name

ieukni-spc-combined-nucala-liquid-issue7draft1.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Improved presentation of SPC

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

Free text change information supplied by the pharmaceutical company

updated section 4.2 to clarify the method of administration in children aged 6 to 11 years old.

Updated on 21 October 2022

File name

ieukni-pl-combined-nucala-pfp-issue9draft1.pdf

Reasons for updating

  • Change to section 3 - how to take/use
  • Improved presentation of PIL

Free text change information supplied by the pharmaceutical company

updated section 3 of PIL, how to use for children aged 6 to 11 years.

Updated on 11 May 2022

File name

ieukni-pl-combined-nucala-pfp-issue8draft1-compendia.pdf

Reasons for updating

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

Updated on 11 May 2022

File name

ieukni-spc-combined-nucala-liquid-issue6draft1-compendia.pdf

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 8 - Marketing authorisation number(s)
  • 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 01 December 2021

File name

ieukni-pl-combined-nucala-pfp-issue7draft1-compendia.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision
  • Change to other sources of information section
  • Change to information for healthcare professionals

Updated on 01 December 2021

File name

ieukni-spc-combined-nucala-liquid-issue5draft1-compendia.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 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)
  • 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 01 December 2021

File name

ieukni-spc-combined-nucala-liquid-issue5draft1-compendia.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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)
  • 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 June 2021

File name

ie-spc-nucala-liquid-issue4draft1-clean.pdf

Reasons for updating

  • Change to section 6.3 - Shelf life
  • 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 June 2021

File name

ie-pl-nucala-pfp-issue6draft1-clean.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 12 February 2021

File name

ie-pl-nucala-pfp-issue5draft1-clean.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 20 August 2020

File name

ie-pl-nucala-pfp-issue4draft1-medie.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Removal of Black Inverted Triangle
  • Improved presentation of PIL

Updated on 20 August 2020

File name

ie-spc-nucala-liquid-issue3draft1-medie.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text
  • Removal of Black Inverted Triangle

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

Updated on 19 February 2020

File name

ie-pl-nucala-pfp-issue3draft1-clean-medicines.ie.pdf

Reasons for updating

  • New PIL for new product

Updated on 19 February 2020

File name

ie-spc-nucala-liquid-issue2draft1-clean-medicines.ie.pdf

Reasons for updating

  • New SPC for new product

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