BESPONSA 1 mg powder for concentrate for solution for infusion
*Company:
Pfizer Healthcare IrelandStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
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
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
Updated on 03 July 2017
Reasons for updating
- New PIL for new product