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Rozlytrek 50 mg film coated granules in sachet

*
Pharmacy Only: Prescription

  • Company:

    Roche Registration GmbH

  • Status:

    No Recent Update

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

  • Active Ingredient(s):

    Entrectinib

    This medicinal product is subject to additional monitoring.

    *Additional information is available within the SPC or upon request to the company

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Updated on 01 April 2025

File name

ROZ_PSUSA_granules_PIL_24Mar2025.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 01 April 2025

File name

ROZ_PSUSA_granules_PIL_24Mar2025.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 01 April 2025

File name

ROZ_PSUSA_granules_PIL_24Mar2025.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 01 April 2025

File name

ROZ_PSUSA_granules_PIL_24Mar2025.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 01 April 2025

File name

ROZ_PSUSA_granules_PIL_24Mar2025.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 01 April 2025

File name

ROZ_PSUSA_granules_SmPC_24Mar2025.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 03 July 2024

File name

ROZ_II17G_Granules_SmPC_dated 27Jun2024.pdf

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 03 July 2024

File name

ROZ_II17G_Granules_PIL_dated 27Jun2024.pdf

Reasons for updating

  • New PIL for new product

Roche Registration GmbH

Roche Registration GmbH