Adtralza 150 mg solution for injection in pre filled syringe * Pharmacy Only: Prescription
Company:
LEO PharmaStatus:
No Recent UpdateLegal 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 03 November 2022
File name
6363aa02d8122.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
63610fd816689.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
63610ca52f65c.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_1645808895.pdf
Reasons for updating
- New PIL for new product
Updated on 25 February 2022
File name
ie-spc-adtralza-20210617-grant_1645808685.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)