TAKHZYRO 150 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 04 June 2026
File name
IE-Takhzyro-SmPC-150-300mg-CCDSV8.0-May26-Clean.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 6.1 - List of excipients
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The update includes the addition of injection site urticaria as an adverse event and the inclusion of the Polysorbate 80 excipient statement in accordance with the revised EU excipients guideline.
Updated on 04 June 2026
File name
IE-Takhzyro-150mg pfs-PIL-CCDSV8-Clean-Jun26.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 4 - possible side effects
- Change to section 6 - what the product contains
Free text change information supplied by the pharmaceutical company
The update includes the addition of injection site urticaria as an adverse event and the inclusion of the Polysorbate 80 excipient statement in accordance with the revised EU excipients guideline.
Updated on 30 April 2025
File name
ie-smpc-takhzyro-150mg-300mg-04-2025-clean.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 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update based on final study reports of phase 3 clinical studies
Updated on 03 April 2024
File name
ie-ni-pl-takhzyro-150mgpfs-03-2024-clean.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 3 - how to take/use
- 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
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated SmPC to include 150mg strength
Updated on 29 November 2023
File name
takhzyro - spc- ie ni - line extension 300 and 150-clean-approved.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated SmPC to include 150mg strength
Updated on 29 November 2023
File name
takhzyro - spc- ie ni - line extension 300 and 150-clean-approved.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated SmPC to include 150mg strength
Updated on 29 November 2023
File name
ie-ni-pl-takhzyro-150mgpfs-line extension-approved.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
New PIL for 150mg strength
Takeda Products Ireland Ltd
Address:
5 Riverwalk Citywest Business Campus Dublin 24Medical Information E-mail:
medinfoemea@takeda.comMedical Information Direct Line:
1800 937970 , +44 3333 000 181