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

  • Name:

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

  • Company:
    info
  • Active Ingredients:

    Polatuzumab Vedotin

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 16/12/20

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Summary of Product Characteristics last updated on medicines.ie: 16/12/2020
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

Click on this link to Download PDF directly

Roche Registration GmbH

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Medicine Name Polivy 140 mg and 30 mg powder for concentrate for solution for infusion Active Ingredients Polatuzumab Vedotin
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When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 16 December 2020 SPC

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 PIL

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 SPC

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 PIL

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 SPC

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 PIL

Reasons for updating

  • New PIL for new product