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Gavreto 100 mg hard capsules

*
Pharmacy Only: Prescription DHPC

  • Company:

    Roche Registration GmbH

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Pralsetinib

    This medicinal product is subject to additional monitoring.

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

Updated on 02 April 2024

File name

PIL_Gavreto_II.012_25Mar.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 02 April 2024

File name

SmPC_Gavreto_II.012_25Mar.pdf

Reasons for updating

  • 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 10 - Date of revision of the text

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

Updated on 21 March 2024

File name

GAV-EN-VII17-180324-Clean_SmPC_1.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 9 - Date of first authorisation/renewal of the authorisation

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

Updated on 23 August 2023

File name

Gavreto_II-0013_20Jul2023_Clean PIL.pdf

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility

Updated on 23 August 2023

File name

Gavreto_II-0013_20Jul2023_Clean SmPC.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.3 - Preclinical safety data

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

Updated on 09 August 2023

File name

GAV-EN-VII10-170723-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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • 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

Gavreto-EN-PSUSA23-220523-Clean-CD_07072023_SmPC.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 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 14 July 2023

File name

Gavreto-EN-PSUSA23-220523-Clean-CD_07072023_PIL.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to date of revision

COM Updated on 19 June 2023

File name

Gavreto_DHPC_Jun 2023_Final Signed version.pdf

Reasons for updating

  • Add New Doc

Updated on 15 June 2022

File name

GAV_IB08_SmPC_09Jun2022_1.pdf

Reasons for updating

  • 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 28 March 2022

File name

GAV_IB04G_PIL_22Mar2022_Clean.pdf

Reasons for updating

  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 28 March 2022

File name

GAV_IB04G_SmPC_22Mar2022_Clean.pdf

Reasons for updating

  • 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 24 November 2021

File name

GAV_IAin_PIL_23Nov2021_clean.pdf

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - manufacturer

Updated on 24 November 2021

File name

GAV_IAin_SmPC_23Nov2021_clean.pdf

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - manufacturer

Updated on 24 November 2021

File name

GAV_IAin_SmPC_23Nov2021_clean.pdf

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • 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 22 November 2021

File name

GAV_Initial MAA_PIL_18 Nov 2021.pdf

Reasons for updating

  • New PIL for new product

Updated on 22 November 2021

File name

GAV_Initial MAA_SmPC_18 Nov 2021.pdf

Reasons for updating

  • New SPC for new product

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