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 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