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IBRANCE 75 mg 100mg & 125mg hard capsules

  • Name:

    IBRANCE 75 mg 100mg & 125mg hard capsules

  • Company:
    info
  • Active Ingredients:

    Palbociclib

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 11/12/19

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Summary of Product Characteristics last updated on medicines.ie: 30/6/2020
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.

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Pfizer Healthcare Ireland

Pfizer Healthcare Ireland

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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 30 June 2020 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)

Updated on 20 February 2020 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

SPC:

New SPC to reflect the new Pfizer Marketing Authorisation for TABLETS

CAPSULE SPC updated sections: Section 4.8 clarification statement added. Minor formatting changes throughout.

 

Updated on 11 December 2019 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

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

Updated on 11 December 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 22 November 2019 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 22 November 2019 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

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: Updated sections 4.2, 4.4 and 4.8 of the SmPC  in order to add ILD/pneumonitis as ADRs together with relevant discontinuation recommendations and a warning based on a safety cumulative review.

Updated on 22 November 2019 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 18 November 2019 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 15 July 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 28 March 2019 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 28 March 2019 SmPC

Reasons for updating

  • Change to section 5.3 - Preclinical safety data

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

Updated on 14 February 2019 PIL

Reasons for updating

  • Change to section 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 14 January 2019 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 14 January 2019 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • 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 SPC has been updated as follows:
Summary of Changes:

  • Section 5.1 - Clinical Efficacy - PALOMA-2 (combination w letrozole) -update to include efficacy data at 31-May-2017 cut-off. PFS data update; Table 6 Efficacy Results update; Kaplan Meier plot update; Table 7 Results in visceral and non-visceral disease; as well as inclusion of new table (8) for Time to initiation of subsequent anticancer therapies and subgroup analysis for stratification factors.
  • Use in Pediatric population - update to Sections 4.2 (Dosing) and 5.2 (Special Populations) re: use in adolescents at age 18 has been established.
  • Section 5.3 - Impairment of Fertility - correction of exposure rate from greater than/equal 7 to greater than /equal to 9 time in findings observed in rats and/or dogs.

Section 4.2 - Posology - editorial update to include instructions in aromatase inhibitors.

The PIL is updated with date change only.

Updated on 7 September 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 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 3 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 8 February 2018 PIL

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 8 February 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 8 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 8 February 2018 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

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 6.5 updated to add 63 capsule pack size for 75/100 and 125 mg presentations

Updated on 30 January 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 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: Sections 4.2, 4.4 and 5.2 updated following  submission of the full reports on hepatic and renal impaired patients clinical studies A5481013 and A5481014

Updated on 26 January 2018 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 18 January 2018 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - 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; Update of sections 4.2, 4.8 and 5.1 of the SmPC in order to reflect independently-reviewed PFS results of study A5481008 (PALOMA-2) and of the Phase 2 portion of the A5481010 single-arm study; the information on ethnicity was also updated in Section 5.2 of the SmPC based on the results of the A5481010 study in Japanese patients:

Updated on 11 January 2018 PIL

Reasons for updating

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

Updated on 5 April 2017 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 updated to change shelf life from 2 to 3 years

Updated on 4 April 2017 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 20 January 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 19 January 2017 PIL

Reasons for updating

  • New PIL for new product