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

  • Company:

    Pfizer Healthcare Ireland
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

    This medicinal product is subject to additional monitoring.

    *Additional information is available within the SPC or upon request to the company

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 19 August 2021

File name

DEC202156033_Adv SPC BO 22_0 IE clean_1629384238.pdf

Reasons for updating

  • 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 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:

Section 4.4 Special warnings and precautions for use – Renal impairment This

section is updated to include data from the final clinical study reports to further

support that a clinically significant decline in renal function is recognised as a class

effect of all tyrosine kinase inhibitor(s) (TKIs) used in CML patients. 

 

Section 4.8 Undesirable effects – entire section is updated based on final results from clinical study B18711053 - where the frequencies of several adverse events have been increased, thus leading to an upgrading and change of the frequency category for the adverse events; Drug hypersensitivity, Dizziness, Pleural effusion, Pulmonary hypertension, Pancreatitis, Hepatic enzyme increased/Hepatocellular injury, Pruritus and Erythema multiforme.

 

Section 5.1 Pharmacodynamic properties – Clinical efficacy This section is updated

to include the results of long-term endpoints up to 60 months where the data

continues to  demonstrate superior efficacy of bosutinib (400 mg) over imatinib.

Tables detailing the the efficacy results of major molecular response (MMR) and

complete cytogenetic response (CCyR) have additionally been updated.

 

Section 9: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION. Update "Date of latest renewal" to 11 February 2021

 

Updated on 19 August 2021

File name

DEC202156033_Adv PIL BO 21_0 IE clean_1629384010.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 21 December 2020

File name

DEC202084274_Adv SPC BO 21_0 IE_1608562523.pdf

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:

 1.     ADR addition to Section 4.4:Photosensitivity

Exposure to direct sunlight or UV radiation should be avoided or minimised due to the risk of photosensitivity associated with bosutinib treatment. Patients should be instructed to use measures such as protective clothing and sunscreen with high sun protection factor (SPF)

 

2.     Section 4.8 - The following adverse reaction photosensitivity is added under the SOC “skin and subcutaneous tissue disorders” with a frequency common: Photosensitivity reaction.

Updated on 21 December 2020

File name

DEC202084274_ADV PIL BO 20_0 IE_1608562442.pdf

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 15 October 2020

File name

DEC202068708_Adv SPC BO 20_0 IE_1602755744.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.3 - Preclinical safety data

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

Updated on 15 October 2020

File name

DEC202068708_ADV PIL BO 19_0 IE_1602755664.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 6 - date of revision

Updated on 24 September 2020

File name

ADV PIL BO 16_0 UK_1600963905.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to other sources of information section
  • Removal of one or more presentations from joint PIL

Updated on 21 August 2020

File name

DEC202055404_Adv SPC BO 19_1 IE_1597999563.pdf

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

File name

DEC201932916_ADV PIL BO 14_0 UK IE clean_1561636003.pdf

Reasons for updating

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

Updated on 27 June 2019

File name

DEC201932916_Adv SPC BO 18_0 IE clean_1561636041.pdf

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

File name

ADV PIL BO 13_0 UK IE clean_1551278106.pdf

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

File name

Adv SPC BO 17_0 IE clean_1551278251.pdf

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 08 August 2018

File name

ADV PIL BO 12_0 UK IE clean_1533730997.pdf

Reasons for updating

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

Updated on 08 August 2018

File name

Adv SPC BO 16_0 IE clean_1533731080.pdf

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

File name

ADV PIL BO 11_0 UK IE clean.pdf

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

File name

Adv_SPC_BO_15_1_IE_clean.docx

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

File name

Adv_SPC_BO_14_0_IE_clean.docx

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

File name

Adv_SPC_BO_13_0_IE_Clean.docx

Reasons for updating

  • New SPC for new product

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

Updated on 11 May 2018

File name

Adv_SPC_BO_13_0_IE_Clean.docx

Reasons for updating

  • New SPC for new product

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

Updated on 11 May 2018

File name

Adv_SPC_BO_13_0_IE_Clean.docx

Reasons for updating

  • New SPC for new product

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

Updated on 08 May 2018

File name

Adv_SPC_BO_13_0_IE_Clean.docx

Reasons for updating

  • New SPC for new product

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

Updated on 02 May 2018

File name

Adv_SPC_BO_13_0_IE_Clean.docx

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

File name

ADV PIL BO 10_0 UK IE clean.pdf

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

File name

Adv_SPC_BO_13_0_IE_Clean.docx

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

Reasons for updating

  • New SPC for new product

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

Updated on 16 February 2018

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 14 February 2018

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

File name

PIL_15807_880.pdf

Reasons for updating

  • New PIL for new product

Updated on 14 February 2018

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

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

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

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 04 April 2017

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 03 April 2017

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

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

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 08 July 2016

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 06 July 2016

Reasons for updating

  • Change to date of revision

Updated on 11 May 2016

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 06 May 2016

Reasons for updating

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

Updated on 01 December 2015

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

Reasons for updating

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

Updated on 19 November 2015

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

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

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

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

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 05 August 2014

Reasons for updating

  • Improved electronic presentation

Updated on 08 July 2014

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 04 July 2014

Reasons for updating

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

Updated on 05 March 2014

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

Reasons for updating

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

Updated on 01 August 2013

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 01 August 2013

Reasons for updating

  • New PIL for new product