Nucala 100 mg powder for solution for injection *

  • Company:

    GlaxoSmithKline (Ireland) Ltd
  • Status:

    No Recent Update
  • 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

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 18 June 2021

File name

ie-pl-nucala-lyo-issue9draft1-clean_1624043285.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 20 August 2020

File name

ie-pl-nucala-lyo-issue8draft1-medie_1597942617.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-lyo-issue11draft1-medie_1597942537.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 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 16 December 2019

File name

ie-pl-nucala-lyo-issue7draft1-clean-medicines.ie_1576506345.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 16 December 2019

File name

ie-spc-nucala-lyo-issue10draft1-clean_1576506251.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • 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 16 December 2019

File name

ie-pl-nucala-lyo-issue7draft1-clean_1576506170.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 05 November 2019

File name

ie-pl-nucalalyo-issue6draft1-clean_1572951635.pdf

Reasons for updating

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

Updated on 16 September 2019

File name

ie-pl-nucala-lyo-issue5draft2-medicines.ie_1568643056.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 11 June 2019

File name

ie-spc-nucala-issue8draft1_1560237464.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • 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

Inclusion of data from Open Label Extension studies into section 4.8 and 5.1.

Updated on 19 March 2019

File name

ie-pl-nucala-issue4draft1-MED.IE_1553009732.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect

Updated on 19 March 2019

File name

ie-spc-nucala-issue7draft1-MED.IE_1553009823.pdf

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

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

Free text change information supplied by the pharmaceutical company

Updated to reflect single market reporting details

Updated on 12 October 2018

File name

ukie-pl-nucala-issue3-draft2-clean-Med.Comps_1539351029.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 11 September 2018

File name

ie-pl-nucala-meds.ie_1536661707.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • 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 2 - use in children and adolescents
  • Change to section 3 - dose and frequency
  • Change to section 3 - use in children/adolescents
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 11 September 2018

File name

ie-spc-nucala-meds.ie_1536661460.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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • 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)

Free text change information supplied by the pharmaceutical company

4.1 Update to include , adolescents and children aged 6 years and older
4.2 Updated to include dosage for ,adolescents and children aged 6 years and older, special populations has also been updated to reflect this change.
4.4 Update to include traceability.
4.8 Addition of clinical trials information to support adolescent and child indication
5.1 Additional data added to support the paediatric indication
5.2 Additional data added to support the paediatric indication
6.6 Addition of instructions for administration of the paediatric dose
 

Updated on 15 June 2018

File name

ukie-spc-nucalaissue5draft1-clean for medsie.docx

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)

Free text change information supplied by the pharmaceutical company

Change to section 6.3 - shelf life changed from 3 to 4 years.

Updated on 01 May 2018

File name

PIL.17402.1 copy.pdf

Reasons for updating

  • New PIL for new product

Updated on 26 January 2018

Reasons for updating

  • New SPC for new product

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

Updated on 26 January 2018

Reasons for updating

  • New SPC for new product

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

Updated on 26 January 2018

Reasons for updating

  • New SPC for new product

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