Adtralza 300 mg solution for injection in pre-filled pen
*Company:
LEO PharmaStatus:
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 08 September 2025
File name
IE-Adtralza_SmPC (September 2025).pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update of sections 4.8 and 5.1 of the SmPC in order to update clinical efficacy and safety information based on the final clinical trial report of the open-label extension PASS study LP0162-1337 (ECZTEND), listed as a category 3 study in the RMP. To also update the PI according to the updated EU Excipient guideline to include a warning regarding polysorbate
Updated on 08 September 2025
File name
IE-Adtralza_PFP_PIL (September 2025).pdf
Reasons for updating
- Change to section 2 - excipient warnings
Free text change information supplied by the pharmaceutical company
Updated in line with the excipients guideline
Updated on 10 July 2025
File name
IE-Adtralza_SmPC (May 2025).pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated shelf-life to 5 years and short-term storage conditions to do not store above 30C for the Adtralza pre-filled syringe.
Updated on 24 October 2023
File name
IE-Adtralza_SmPC (September 2023).pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 24 October 2023
File name
IE-Adtralza_PFP_PIL (September 2023).pdf
Reasons for updating
- New PIL for new product
LEO Pharma
Address:
Cashel Road, Dublin 12Medical Information E-mail:
medical-info.ie@leo-pharma.comTelephone:
+353 1 490 8924Website:
https://www.leo-pharma.ieMedical Information Facsimile:
Not ApplicableMedical Information Direct Line:
+353 1 4908924