BESPONSA 1 mg powder for concentrate for solution for infusion

*
Pharmacy Only: Prescription

Updated on 21 August 2024

File name

Adv PIL BS 14_0 IE & NI - Clean .pdf

Reasons for updating

  • Change to section 4 - how to report a side effect

Updated on 16 January 2024

File name

AdvSPCBS123IEClean.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 5.2 - Pharmacokinetic properties

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 4.2 : Paediatrics updated for available data

Section 4.4 : Editorial

Section 4.6 : Editorial

Section 4.8 : Editorial, update to paediatric and immunogenicity

Section 5.1 : Editorial, ATC code, paediatric population update

Section 5.2 : Editorial, Update to elimination section, paediatric population

Updated on 16 January 2024

File name

AdvPILBS130IENIClean.pdf

Reasons for updating

  • Change to section 2 - use in children and adolescents
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 6 - date of revision

Updated on 13 February 2023

File name

AdvSPCBS112IEClean.pdf

Reasons for updating

  • Document format updated

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

Updated on 22 February 2022

File name

AdvSPCBS112IEClean.pdf

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • 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 5.3 - Preclinical safety data
  • Change to section 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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

The SPC has been updated as follows:

Deletion of Black Triangle

Section 3 - Editorial

Section 4.4 - Editorial

 Section 4.5 - Editorial

Section 4.8 – Editorial and align with QRD

Section 5.1 – Editorial

Section 5.2 – Editorial

Section 5.3 – Editorial

Section 6.3 – Editorial

Section 6.6 – Reference to temperature ‘68°F’ deleted

Section 9 – Update to date of latest renewal

Section 10 – Editorial Update and update to revision date and version

Updated on 22 February 2022

File name

AdvPILBS121IENIClean.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 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals
  • Removal of Black Inverted Triangle
  • Correction of spelling/typing errors

Updated on 12 January 2022

File name

Adv PIL BS 11_1 IE & NI - Clean .pdf

Reasons for updating

  • Change to section 4 - how to report a side effect

Updated on 30 July 2021

File name

DEC202149300_Adv PIL BS 11_0 IE & NI - Clean .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.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.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 .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.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.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_.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.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.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.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.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.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