Nucala 100 mg solution for injection in pre-filled syringe
*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-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 the 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-pfs100-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 to clarify the method of administration in children aged 6 to 11 years old.
Updated on 11 May 2022
File name
ieukni-pl-combined-nucala-pfs100-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
- Correction of spelling/typing errors
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-pfs-issue7draft1-compendia.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 - 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 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-pfs-issue6draft1-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 12 February 2021
File name
ie-pl-nucala-pfs-issue5draft1-clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 20 August 2020
File name
ie-pl-nucala-pfs-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 4.4 - 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 6.1 - 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-pfs-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)