Nucala 100 mg powder for solution for injection
*Company:
GlaxoSmithKline (Ireland) LtdStatus:
No Recent UpdateLegal 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 21 October 2022
File name
ieukni-pl-combined-nucala-lyo-issue12draft1.pdf
Reasons for updating
- Improved presentation of PIL
Free text change information supplied by the pharmaceutical company
minor corrections to improve the presentation of PIL
Updated on 21 October 2022
File name
ieukni-spc-combined-nucala-lyo-issue14draft1.pdf
Reasons for updating
- 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
Minor corrections to improve the presentation of SPC
Updated on 11 May 2022
File name
ieukni-pl-combined-nucala-lyo-issue11draft1-compendia.pdf
Reasons for updating
- Change to section 6 - date of revision
- Improved presentation of PIL
Updated on 11 May 2022
File name
ieukni-spc-combined-nucala-lyo-issue13draft1-compendia.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 6.5 - Nature and contents of container
- 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-lyo-issue10draft1-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 4 - how to report a side effect
- 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-lyo-issue12draft1-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 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)
Updated on 18 June 2021
File name
ie-pl-nucala-lyo-issue9draft1-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 20 August 2020
File name
ie-pl-nucala-lyo-issue8draft1-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-lyo-issue11draft1-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 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.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.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.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.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.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 11 June 2019
File name
ie-spc-nucala-issue8draft1.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.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.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.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.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.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)