TAKHZYRO 300 mg solution for injection in pre-filled pen
*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-300mg pfp-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 12 May 2025
File name
ie-smpc-takhzyro-150mg-300mg-04-2025-tracked.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
Addition of new section for Pen formulation in medicines ie
Updated on 12 May 2025
File name
ie-pil-takhzyro-300mgPEN-02-2025.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
Addition of Pen formulation to Medicines.ie
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