BESPONSA 1 mg powder for concentrate for solution for infusion

  • Name:

    BESPONSA 1 mg powder for concentrate for solution for infusion

  • Company:
    info
  • Active Ingredients:

    Inotuzumab ozogamicin

  • 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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Summary of Product Characteristics last updated on medicines.ie: 23/8/2019
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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Pfizer Healthcare Ireland

Pfizer Healthcare Ireland

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Medicine Name BESPONSA 1 mg powder for concentrate for solution for infusion Active Ingredients Inotuzumab ozogamicin
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1 - 0 of 227 items.Total: Infinity pages

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

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 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

None provided

Updated on 3 July 2017 PIL

Reasons for updating

  • New PIL for new product