Adtralza 150 mg solution for injection in pre filled syringe
*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_PFS_PIL (May 2025).pdf
Reasons for updating
- Change to section 5 - how to store or dispose
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
The shelf-life has been updated to 5 years and short-term storage conditions have been updated to Do not store above 30C for the Adtralza pre-filled syringe.
Updated on 24 October 2023
File name
IE-Adtralza_PFS_PIL (September 2023).pdf
Reasons for updating
- Change to section 2 - use in children and adolescents
- Change to section 3 - dose and frequency
Updated on 24 October 2023
File name
IE-Adtralza_SmPC (September 2023).pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- 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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.3 - Shelf life
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 8 - Marketing authorisation number(s)
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 03 November 2022
File name
IE-Adtralza-SmPC-202210-ddi.pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
DDI update October 2022
Updated on 01 November 2022
File name
IE-Adtralza-PIL-202210-adol.pdf
Reasons for updating
- 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 3 - use in children/adolescents
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Adolescent indication update
Updated on 01 November 2022
File name
IE-Adtralza-SmPC-202210-adol.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Adolescent indication updates
Updated on 25 February 2022
File name
ie-pil-adtralza-20210617-grant.pdf
Reasons for updating
- New PIL for new product
Updated on 25 February 2022
File name
ie-spc-adtralza-20210617-grant.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
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