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Rozlytrek 100 mg and 200 mg hard capsules

*
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

Updated on 14 July 2023

File name

ENT-EN-R15-220523-Clean-CD_SmPC_1.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • 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 14 July 2023

File name

ENT-EN-R15-220523-Clean-CD_PL_1.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to date of revision

Updated on 17 March 2023

File name

ENT-EN-VII14-200223-Clean-CD_SmPC_1.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.2 - Pharmacokinetic properties
  • 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 17 March 2023

File name

ENT-EN-VII14-200223-Clean-CD_PL_1.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 14 October 2022

File name

Rozlytrek-EN-VII12-101022-Clean-CD_SmPC_1.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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 30 June 2022

File name

ROZ_IB11_SmPC_dated 27Jun2022.pdf

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • 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 30 June 2022

File name

ROZ_IB11_SmPC_dated 27Jun2022.pdf

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.3 - Shelf life
  • 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 30 June 2022

File name

ROZ_IB11_PIL_dated 27Jun2022.pdf

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 07 June 2022

File name

ROZ_R07_SmPC_dated 30 May 2022.pdf

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • 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 07 June 2022

File name

ROZ_R07_PIL_dated 30 May 2022.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to date of revision

Updated on 17 August 2021

File name

Rozlytrek_PIL_IB-0005G_clean.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 17 August 2021

File name

Rozlytrek_SmPC_IB-0005G_clean.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.3 - Shelf life
  • 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 07 July 2021

File name

Rozlytrek_SmPC_R_21Jun2021_clean.pdf

Reasons for updating

  • 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 20 October 2020

File name

Rozlytrek_SmPC_IB01_15Oct2020_clean.pdf

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors
  • Change to section 5 - Pharmacological properties

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

Updated on 20 October 2020

File name

Rozlytrek_PIL_IB01_15Oct2020_clean.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 10 August 2020

File name

Rozlytrek SmPC_31Jul2020.pdf

Reasons for updating

  • New SPC for new product

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

Updated on 10 August 2020

File name

Rozlytrek PIL_31Jul2020.pdf

Reasons for updating

  • New PIL for new product