BESPONSA 1 mg powder for concentrate for solution for infusion
- Name:
BESPONSA 1 mg powder for concentrate for solution for infusion
- Company:
Pfizer Healthcare Ireland
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 18/11/19
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Pfizer Healthcare Ireland
Company Products
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 18 November 2019 PIL
Reasons for updating
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 23 August 2019 PIL
Reasons for updating
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 23 August 2019 SmPC
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 9 October 2018 PIL
Reasons for updating
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 9 October 2018 SmPC
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 PIL
Reasons for updating
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 23 August 2018 SmPC
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 3 August 2018 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 3 August 2018 SmPC
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 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 14 December 2017 SmPC
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 PIL
Reasons for updating
- New PIL for new product
Updated on 11 December 2017 PIL
Reasons for updating
- Change to section 6 - date of revision
Updated on 14 November 2017 SmPC
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 SmPC
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 3 July 2017 PIL
Reasons for updating
- New PIL for new product