Bavencio 20 mg/mL concentrate for solution for infusion *

  • Company:

    Merck - Pfizer
  • 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

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 26 January 2021

File name

Bavencio PIL - TW2494580, TW2669961 - Jan 2021 - clean_1611678412.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Changes include: Addition of new indication - urothelial carcinoma (UC) & shelf life extension to 3 years.

Our ref: TW2494580, TW2669961
 

Updated on 26 January 2021

File name

Bavencio SPC 20mgml UK&IE TW2494580 TW2669961 current v9.0 - clean_1611678282.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 - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • 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)

Free text change information supplied by the pharmaceutical company

Changes include: Addition of new indication - urothelial carcinoma (UC) & shelf life extension to 3 years.

Our ref: TW2494580, TW2669961
 

EDM Updated on 12 October 2020

File name

Bavencio Patient Info Brochure A5 Ireland Sept2020 v1_1602496034.pdf

Reasons for updating

  • Replace File

Free text change information supplied by the pharmaceutical company

Updated with immune-related adverse event myasthenia gravis

EDM Updated on 12 October 2020

File name

Bavencio Patient alert card 55x85mm Ireland Sept2020 v1_1602496034.pdf

Reasons for updating

  • Replace File

Free text change information supplied by the pharmaceutical company

Updated with immune-related adverse event myasthenia gravis

Updated on 29 September 2020

File name

Bavencio 20mgml UK&IE TW2351837 TW2263689 PIL_1601383201.pdf

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

File name

Bavencio 20mgml UK&IE TW2351837 TW2263689 TW2350918 current v8.0_1601382994.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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic 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)

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

EDM Updated on 02 December 2019

File name

MCC Bavencio Patient Info Brochure A5 Ireland Nov19 v2_1575294803.pdf

Reasons for updating

  • Replace File

Updated on 31 October 2019

File name

PIL RCC_1572521281.pdf

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

File name

Bavencio 20mgml UK&IE TW1972145 current v7_1572521052.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 4.8 - 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

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

EDM Updated on 25 July 2019

File name

Final MCC Bavencio Patient Info Brochure A5 Ireland July19 v2 - Panc_1564056319.pdf

Reasons for updating

  • Replace File

EDM Updated on 25 July 2019

File name

Final MCC Bavencio Patient alert card 55x85mm Ireland Jul19 v2 - Panc_1564056304.pdf

Reasons for updating

  • Replace File

Updated on 08 July 2019

File name

Bavencio - Package leaflet - Panctreatitis - TW1972347_1562576354.pdf

Reasons for updating

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

Updated on 05 July 2019

File name

Bavencio 20mgml UK&IE TW1972347 current v6.0_1562323520.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 4.8 - 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)

EDM Updated on 07 June 2019

File name

Patient alert card 55x85mm Ireland v4_1559296145.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 07 June 2019

File name

Bavencio Patient Info Brochure A5 Ireland v4_1559296190.pdf

Reasons for updating

  • Add New Doc

Updated on 09 April 2019

File name

Bavencio_corrigendum_PIL_1554816824.pdf

Reasons for updating

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

Updated on 15 February 2019

File name

Bavencio 20mgml UK&IE TW1971395 current v5.0_1550226543.pdf

Reasons for updating

  • 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 20 September 2018

File name

Bavencio 20mgml UK and IE TW1767401 current v4.0_1537429420.pdf

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic 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 17 July 2018

File name

PIL_17313_183.pdf

Reasons for updating

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

Updated on 17 July 2018

File name

Bavencio 20mgml UK and IE TW1735675 current v3.0 (002).docx

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 03 January 2018

Reasons for updating

  • New SPC for new product

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

Updated on 03 January 2018

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 02 January 2018

File name

PIL_17313_183.pdf

Reasons for updating

  • New PIL for new product

Updated on 02 January 2018

Reasons for updating

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

Updated on 27 September 2017

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

Reasons for updating

  • New PIL for new product