TAKHZYRO 300 mg solution for injection in pre-filled syringe
*Company:
Takeda Products Ireland LtdStatus:
UpdatedLegal 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 03 April 2024
File name
ie-ni-pl-takhzyro-300mg pfs-03-2024-clean.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Minor editorial updates.
Updated on 29 November 2023
File name
takhzyro - spc- ie ni - line extension 300 and 150-clean-approved.pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- 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 5.3 - Preclinical safety data
- Change to section 6.3 - Shelf life
- 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 9 - Date of first authorisation/renewal of the authorisation
- 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
Update to include the paediatric indication from 2years and above
Updated on 29 November 2023
File name
takhzyro - spc- ie ni - line extension 300 and 150-clean-approved.pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- 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 5.3 - Preclinical safety data
- Change to section 6.3 - Shelf life
- 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 9 - Date of first authorisation/renewal of the authorisation
- 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
Update to include the paediatric indication from 2years and above
Updated on 29 November 2023
File name
ie-ni-pl-takhzyro-300mg pfs-line extension-approved.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 3 - dose and frequency
- Change to section 3 - how to take/use
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 6 - date of revision
- Change to section 7 - Instructions for use
Free text change information supplied by the pharmaceutical company
Update to include the paediatric indication (from 2 years and above)
Updated on 29 November 2023
File name
ie-ni-pl-takhzyro-300mg pfs-line extension-approved.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 3 - dose and frequency
- Change to section 3 - how to take/use
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 6 - date of revision
- Change to section 7 - Instructions for use
Free text change information supplied by the pharmaceutical company
Update to include the paediatric indication (from 2 years and above)
Updated on 29 November 2023
File name
ie-ni-pl-takhzyro-300mg pfs-line extension-approved.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 3 - dose and frequency
- Change to section 3 - how to take/use
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 6 - date of revision
- Change to section 7 - Instructions for use
Free text change information supplied by the pharmaceutical company
Update to include the paediatric indication from 2 years and above
Updated on 29 November 2023
File name
ie-ni-pl-takhzyro-300mg pfs-line extension-approved.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 3 - dose and frequency
- Change to section 3 - how to take/use
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 6 - date of revision
- Change to section 7 - Instructions for use
Free text change information supplied by the pharmaceutical company
Update to include the paediatric indication from 2 years and above
Updated on 23 August 2023
File name
takhzyro-pl-IE NI -pre-filled-syringe-renewal-june23-approved-clean.pdf
Reasons for updating
- 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 6 - date of revision
- Removal of Black Inverted Triangle
Free text change information supplied by the pharmaceutical company
Black triangle removal and minor editorial updates to sections: 1, 2 & 6.
Updated on 23 August 2023
File name
takhzyro-spc-ie-ni-renewal-June-approved-clean.pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- 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)
Free text change information supplied by the pharmaceutical company
Black triangle removal and minor editorial updates to sections: 3, 4.4, 4.7 and 5.
Updated on 13 October 2022
File name
takhzyro-spc-ie-ni-address change-Sep22 -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 13 October 2022
File name
takhzyro-pl-IE NI -pre-filled-syringe-address change-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
Updated on 07 September 2022
File name
takhzyro-pl-IE NI -pre-filled-syringe-local rep -clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 07 September 2022
File name
takhzyro-spc-ie-ni-local rep-Sep22 -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 23 December 2021
File name
takhzyro-pre-filled-syringe-pl-ie+ni+mt-RMP+PI-clean.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 23 December 2021
File name
takhzyro-spc-ie-mt-ni-RMP+PI-clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.4 - Special precautions for storage
- 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 25 November 2021
File name
takhzyro-pre-filled-syringe-pl-ie+ni+mt-Batch Release-clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 13 October 2021
File name
takhzyro-spc-ie-mt-ni-MAT-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 13 October 2021
File name
takhzyro-pre-filled-syringe-pl-ie+ni+mt-MAT-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 20 September 2021
File name
takhzyro-pre-filled-syringe-pl-ie-TIB-16-July20-clean.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 09 February 2021
File name
takhzyro-pre-filled-syringe-pl-ie-TIB-16-July20-clean.pdf
Reasons for updating
- New PIL for medicines.ie
Updated on 09 February 2021
File name
takhzyro-pre-filled-syringe-pl-ie-TIB-16-July20-clean.pdf
Reasons for updating
- New PIL for new product
Updated on 09 February 2021
File name
takhzyro-spc-ie-mt-TIB-16-24July20-clean.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)