Tezspire 210 mg solution for injection in pre-filled pen
*Company:
AstraZeneca Pharmaceuticals (Ireland) DACStatus:
UpdatedLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
This medicinal product is subject to additional monitoring.
*Additional information is available within the SPC or upon request to the company
Updated on 29 October 2025
File name
20251020 SPC IE MT Tezspire PFP 210mg CRSwNP indication RSP 25 0010.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- 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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 29 October 2025
File name
20251020 Package Leaflet IE MT Tezspire PFP 210mg CRSwNP indication RSP 25 0011.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 2 - excipient warnings
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
Updated on 08 August 2025
File name
20250725 Package Leaflet IE MT Tezspire PFP 210mg Add SBC and IFU Updates RSP 25 0004.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
Free text change information supplied by the pharmaceutical company
Addition of IFU to the PIL.
Updated on 08 August 2025
File name
20250725 Package Leaflet IE MT Tezspire PFP 210mg Add SBC and IFU Updates RSP 25 0004.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
Free text change information supplied by the pharmaceutical company
Addition to IFU to the leaflet
Updated on 14 March 2024
File name
20230921 Package Leaflet IE MT Tezspire PFP 210mg Postcode Update RSP 23 0018.pdf
Reasons for updating
- New PIL for new product
Updated on 14 March 2024
File name
20230915 SPC IE MT Tezspire PFP PFS 210mg Anaphylaxis PRAC RSP 23 0012.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
AstraZeneca Pharmaceuticals (Ireland) DAC
 DAC.webp)
Address:
College Business and Technology Park, Blanchardstown Road North, Dublin 15, D15 R925Medical Information E-mail:
mipqc.ireland@astrazeneca.comTelephone:
+353 1 609 7100Fax:
+353 1 686 5038Website:
https://contactazmedical.astrazeneca.comMedical Information Direct Line:
1800800899