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Bosulif 100 mg, 400 mg & 500 mg film-coated tablets

  • Name:

    Bosulif 100 mg, 400 mg & 500 mg film-coated tablets

  • Company:
    info
  • Active Ingredients:

    Bosutinib monohydrate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 27/06/19

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Summary of Product Characteristics last updated on medicines.ie: 21/8/2020
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.

Click on this link to Download PDF directly

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
Medicine Name Bosulif 100 mg, 400 mg & 500 mg film-coated tablets Active Ingredients Bosutinib monohydrate
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1 - 0 of 232 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 21 August 2020 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 9 - Date of first authorisation/renewal of the authorisation

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

Updated on 27 June 2019 PIL

Reasons for updating

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

Updated on 27 June 2019 SmPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.3 - Preclinical safety data

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

Updated on 27 February 2019 PIL

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - dose and frequency
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 27 February 2019 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 9 - Date of first authorisation/renewal of the authorisation

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: QRD changes to sections 4.2, 4.8, 5.2, 5.2, 6.1 and 9

Updated on 8 August 2018 PIL

Reasons for updating

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

Updated on 8 August 2018 SmPC

Reasons for updating

  • 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 10 – Date of revision of text

Updated on 29 May 2018 PIL

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
  • Introduction of new strength

Updated on 29 May 2018 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)

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: sections 1, 2, 3, 6.1, 6.5, 8 updated to make reference 400mg presentation and minor editorial changes to sections 4.4, 4.6 and 4.8

Updated on 22 May 2018 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 10 - Date of revision of the text

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

Updated on 17 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 11 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 11 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 8 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 2 May 2018 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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
  • Change to section 5.3 - Preclinical safety data
  • 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 in sections 4.1, 4.2, 4.4, 4.5, 4.6, 4.8, 5.1, 5.2, 5.3, 9 &10 for the extension of indication to:  newly diagnosed chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukaemia (Ph+ CML)

Updated on 26 April 2018 PIL

Reasons for updating

  • 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 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - how to take/use
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 24 April 2018 SmPC

Reasons for updating

  • 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: spc section 5.2 subsections distribution and elimination updated for the absolute PK value derived from study 1044:

Updated on 16 February 2018 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.3 - Preclinical safety data

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

Free text change information supplied by the pharmaceutical company

The following changes to the labelling have been approved.  Please refer to attached copy/copies of labelling documentation for full details.

 

The SPC has been updated as follows: section 4.8 and 5.3 to make editorial changes

Updated on 16 February 2018 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 February 2018 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.3 - Preclinical safety data
  • SPC submitted in error

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

Free text change information supplied by the pharmaceutical company

The following changes to the labelling have been approved.  Please refer to attached copy/copies of labelling documentation for full details.

 

The SPC has been updated as follows: to make editorial changes to section 4.8 and 5.3

Updated on 14 February 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 14 February 2018 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 13 February 2018 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision
  • Submitted in error

Updated on 27 April 2017 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)
  • 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: Minor stylistic changes in section 4.1-4.5, 4.8, 5.1-5.3, 6.1, 6.5, 8, 9 & 10

Updated on 21 April 2017 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 4 April 2017 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)
  • 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: Minor stylistic changes in section 4.1-4.5, 4.8, 5.1-5.3, 6.1, 6.5, 8, 9 & 10

Updated on 3 April 2017 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 15 December 2016 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

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; Sections 4.4, and 4..8. Add Severe skin reactions: Bosulif can induce severe skin reactions such as Stevens-Johnson syndrome and Toxic Epidermal Necrolysis in section 4.4 and  include ADR  Stevens-Johnson Syndrome and toxic Epidermal Necrolysis and Tumour lysis syndrome in section 4.8. Following PRAC assessment of PSUR 5

Updated on 14 December 2016 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 8 July 2016 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 update to the SPC and PIL to what was previously issued is the date of revision and regulatory reference number. 

Date of revision updated from 04/2016 to 05/2016 to reflect the date EMA accepted the Type IA notification and as advise by Above country regulatory

Updated on 6 July 2016 PIL

Reasons for updating

  • Change to date of revision

Updated on 11 May 2016 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

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:

Sections 4.4 and 4.8  - Addition of Hepatitis B reactivation

Updated on 6 May 2016 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 1 December 2015 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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 4.8 - Addition of the Adverse reaction – hypertension

Updated on 26 November 2015 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 19 November 2015 SmPC

Reasons for updating

  • 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:

5.2     Pharmacokinetic properties

- Update the Pharmacokinetic properties information after analysis of final study report for study B1871044 in fulfilment of MEA 005.2

Updated on 18 August 2015 SmPC

Reasons for updating

  • 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 - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic 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 4.4:

Replacement of the word ‘ potent’ with ‘strong’  within this section.

Section 4.5 :

 

CYP3A inhibitors – text updated( please refer to tracked SPC to view changes)

CYP3A inducers – text updated ( please refer to tracked SPC to view changes)

 

Effects of bosutinib on other medicinal products - text updated ( please refer to tracked SPC to view changes)

 

Section 4.8

Update from IMB to HPRA

 

Section 5.1

Minor editing changes

Updated on 17 August 2015 PIL

Reasons for updating

  • Change to side-effects
  • Change to drug interactions
  • Change to further information section
  • Change to date of revision

Updated on 12 January 2015 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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 – Shelf life update to 4 years.

Section 4.5 – paragraph ‘ Proton pump inhibitors’ -  spelling correction ‘ bosutinib’

 

Updated on 24 November 2014 SmPC

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 scope of the variation was to update section 4.4 of the SmPC with regard to renal impairment and the effect of bosutinib on estimated glomerular filtration rate (eGFR) over time.

Updated on 5 August 2014 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 8 July 2014 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 5.2 - Pharmacokinetic properties
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - MA number

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

Free text change information supplied by the pharmaceutical company

Updates to Sections 4.2, 4.4, 5.2, 6.5 & 8

 

Updated on 4 July 2014 PIL

Reasons for updating

  • Change to date of revision
  • Change to dosage and administration
  • Introduction of new pack/pack size

Updated on 5 March 2014 SmPC

Reasons for updating

  • Addition of black triangle
  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

Update to additional monitoring statement
Update to section 4.8

Updated on 27 February 2014 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 1 August 2013 PIL

Reasons for updating

  • New PIL for new product

Updated on 1 August 2013 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