BESPONSA 1 mg powder for concentrate for solution for infusion

Product Information *

  • Company:

    Pfizer Healthcare Ireland
  • Status:

    Updated
  • Active Ingredients :

    This medicinal product is subject to additional monitoring.

    *Additional information is available upon request

  • Legal Category:

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

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 30 July 2021

File name

DEC202149300_Adv PIL BS 11_0 IE & NI - Clean _1627649162.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 12 November 2020

File name

DEC202070883_clean ADV SPC BS 10_0_1605181650.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

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

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

In section 4.4 Special warnings and precautions for use, the addition of Sodium content excipient information

 

Updated on 12 November 2020

File name

DEC202070883_clean ADV PIL BS 10_0 IE_1605181600.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - what the product contains
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 18 November 2019

File name

DEC201964105_clean ADV PIL BS 7_0 _1574077401.pdf

Reasons for updating

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

Updated on 23 August 2019

File name

DEC201945355_ADV PIL BS 6_0 clean_1566550582.pdf

Reasons for updating

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

Updated on 23 August 2019

File name

DEC201945355_ADV SPC BS 6_0 clean_1566550643.pdf

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Updated on 09 October 2018

File name

ADV PIL BS 5_0 clean__1539082531.pdf

Reasons for updating

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

Updated on 09 October 2018

File name

ADV SPC BS 5_0 clean_1539082633.pdf

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: Section 6.3 is update with the new shelf-life

Updated on 23 August 2018

File name

ADV PIL BS 4_0 clean_1535019976.pdf

Reasons for updating

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

Updated on 23 August 2018

File name

ADV SPC BS 4_0 clean_1535020075.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 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • 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)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows|; SPC sections:

4.2 –posology update for patients not proceeding to HSRT

4.4 update to posology (number of cycles) due to hepatotoxicity

4.8 Update to frequency of AEs reported for pivotal study

5.1 Update to OS efficacy values pivotal study

5.2 Update to cardiac electrophysiology

5.3 Update to genotoxicity

6.6 Update to IV infusion bag light protection

Updated on 03 August 2018

File name

ADV PIL BS 3_0 UK IE clean_1533305274.pdf

Reasons for updating

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

Updated on 03 August 2018

File name

ADV SPC BS 3_0 UK IE clean_1533305429.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows|;
SECTION 7 – Change to MAH

SECTION 4.8 – UK AE reporting:  Yellow card update

SECTION 10 – Date of revision of text

Updated on 14 December 2017

Reasons for updating

  • New SPC for new product

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

Updated on 14 December 2017

Reasons for updating

  • 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

The SPC has been updated as follows: SPC date is updated to reflect the updated approval date of the annex.

Updated on 11 December 2017

File name

PIL_17204_67.pdf

Reasons for updating

  • New PIL for new product

Updated on 11 December 2017

Reasons for updating

  • Change to section 6 - date of revision

Updated on 14 November 2017

Reasons for updating

  • Change to legal category

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

Free text change information supplied by the pharmaceutical company

The issue relates to the  legal sub-classification of the prescription medicine selected. So there are two:  sub-category S1A (non-renewable substances) and S1B (renewable substances).

Besponsa is listed as an S1B but Besponsa falls under the S1A category. Can this be updated please?

Updated on 11 July 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 03 July 2017

Reasons for updating

  • New PIL for new product