Polivy 140 mg and 30 mg powder for concentrate for solution for infusion

*
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):

    This medicinal product is subject to additional monitoring.

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

Updated on 31 May 2022

File name

SmPC_Polivy_II-0012_24_May_2022.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - 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 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)

Free text change information supplied by the pharmaceutical company

EMEA/H/C/004870/II/0012. Inclusion of Polarix study Data (1L DLBCL).

Updated on 31 May 2022

File name

PIL_Polivy_II-0012_24_May_2022.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • 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 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - dose and frequency
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects

Updated on 13 May 2021

File name

SmPC_Polivy_IB-007_05-May-2021_clean.pdf

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.3 - Shelf life
  • 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 13 May 2021

File name

PIL_Polivy_IB-007_05-May-2021_clean.pdf

Reasons for updating

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

Updated on 16 December 2020

File name

SmPC_Polivy_R-03_09-Dec-2020_clean.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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • 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 16 December 2020

File name

PIL_Polivy_R-03_09-Dec-2020_clean.pdf

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 13 November 2020

File name

SmPC_Polivy II-02-G_15-Oct-2020_clean.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text
  • Introduction of new pack/pack size

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

Free text change information supplied by the pharmaceutical company

EMEA/H/C/004870/II/0002/G. Inclusion of 30mg formulation, updated transportation and in hold-use times, and compatibilities. 

Updated on 13 November 2020

File name

PIL_Polivy II-02-G_15-Oct-2020_clean.pdf

Reasons for updating

  • Change to section 6 - what the product contains
  • Introduction of new strength

Free text change information supplied by the pharmaceutical company

EMEA/H/C/004870/II/0002/G. Inclusion of 30mg formulation, updated transportation and in hold-use times, and compatibilities. 

Updated on 21 January 2020

File name

SmPC_Polivy_V1.0_MAA_16-Jan-2020.pdf

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

EMEA/H/C/004870/0000. Approval for a new MAA.

Updated on 21 January 2020

File name

PIL_Polivy_V1.0_MAA_16-Jan-2020.pdf

Reasons for updating

  • New PIL for new product