Adtralza 150 mg solution for injection in pre filled syringe *
Pharmacy Only: Prescription

  • Company:

    LEO Pharma
  • Status:

    No Recent Update
  • Legal 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)