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Bavencio 20 mg/mL concentrate for solution for infusion

  • Name:

    Bavencio 20 mg/mL concentrate for solution for infusion

  • Company:
    info
  • Active Ingredients:

    Avelumab

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 29/09/20

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Summary of Product Characteristics last updated on medicines.ie: 29/9/2020
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.

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Merck - Pfizer

Merck - Pfizer

Company Products

Medicine NameActive Ingredients
Medicine Name Bavencio 20 mg/mL concentrate for solution for infusion Active Ingredients Avelumab
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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 12 October 2020 Ed-Ptnt

Reasons for updating

  • Replace document

Free text change information supplied by the pharmaceutical company

Updated with immune-related adverse event myasthenia gravis

Updated on 12 October 2020 Ed-Ptnt

Reasons for updating

  • Replace document

Free text change information supplied by the pharmaceutical company

Updated with immune-related adverse event myasthenia gravis

Updated on 29 September 2020 PIL

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

  1. Addition of myasthenia gravis as an immune-related adverse event
  2. Removal of the ‘conditional’ status of the Marketing Authorisation

Our ref:

TW2351837

TW2263689

Updated on 29 September 2020

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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 9 - Date of first authorisation/renewal of the authorisation

Free text change information supplied by the pharmaceutical company

  1. Addition of myasthenia gravis as an immune-related adverse event
  2. Addition of MCC ‘Part B’ data (specific obligation) and removal of the ‘conditional’ status of the Marketing Authorisation in section 5.1
  3. 3rd annual renewal of the Marketing Authorisation

Our ref:

TW2351837

TW2263689

TW2350918

Updated on 2 December 2019 Ed-Ptnt

Reasons for updating

  • Replace document

Updated on 31 October 2019 PIL

Reasons for updating

  • 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 3 - dose and frequency
  • Change to section 3 - how to take/use
  • Change to section 3 - duration of treatment
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 31 October 2019

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 4.8 - 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 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

Updated on 25 July 2019 Ed-Ptnt

Reasons for updating

  • Replace document

Updated on 25 July 2019 Ed-Ptnt

Reasons for updating

  • Replace document

Updated on 8 July 2019 PIL

Reasons for updating

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

Updated on 5 July 2019

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 4.8 - 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

Updated on 7 June 2019 Ed-Ptnt

Reasons for updating

  • Add New Doc

Updated on 7 June 2019 Ed-Ptnt

Reasons for updating

  • Add New Doc

Updated on 9 April 2019 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 15 February 2019

Reasons for updating

  • Change to section 9 - Date of first authorisation/renewal of the authorisation

Updated on 20 September 2018

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Updated on 17 July 2018 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 17 July 2018

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • 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 3 January 2018

Reasons for updating

  • New SmPC for new product

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

Updated on 3 January 2018 SPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

5.1 Pharmacodynamic properties- ATC code has changed from not yet assigned to L01XC31.

6.3 Shelf life - Under, After preparation of infusion, '(see section 6.6)' has been removed.

6.6 Special precautions for disposal and other handling - 'The diluted solution must not be stored longer than a total of 24 hours under refrigerated conditions, (2°C to 8°C) or up to 8 hours at room temperature (20°C to 25°C)' has been removed.

10. DATE OF REVISION OF THE TEXT - has changed to 12/2017

Updated on 2 January 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 2 January 2018 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 27 September 2017 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

None provided

Updated on 27 September 2017 PIL

Reasons for updating

  • New PIL for new product