Phesgo 600 mg/ 600 mg and 1200 mg/ 600 mg solution for injection *
Pharmacy Only: Prescription

  • Company:

    Roche Registration GmbH
  • Status:

    Updated
  • 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 25 January 2023

File name

63d0f8535bb1b.pdf

Reasons for updating

  • Document format updated

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

Updated on 01 March 2022

File name

Phesgo PIL dated 13 Jan 2022_Clean_1646150236.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 01 March 2022

File name

Phesgo SmPC dated 13 Jan 2022_Clean_1646150059.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 16 November 2021

File name

SmPC Phego II-007_ 23.Sep.2021 clean_1637059939.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Updated on 26 July 2021

File name

SmPC Phesgo clean - 24-Jun-2021_1627299242.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 6.6 - Special precautions for disposal and other handling

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

Updated on 06 January 2021

File name

Phesgo SmPC Clean 21 Dec2020_1609934365.pdf

Reasons for updating

  • New SPC for new product

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

Updated on 06 January 2021

File name

Phesgo PIL Clean 21 Dec 2020_1609934324.pdf

Reasons for updating

  • New PIL for new product