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IBRANCE 75mg, 100mg & 125mg hard capsules *
Pharmacy Only: Prescription

  • Company:

    Pfizer Healthcare Ireland

  • Status:

    Updated

  • Legal Category:

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

  • Active Ingredient(s):

    Palbociclib

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

Updated on 02 June 2023

File name

647990a81c080.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:

Section 4.4 – addition of Venous Thromboembolism (VTE) as a warning/precaution for use

Section 4.8 – addition of Palmar-plantar erythrodysaesthesia syndrome (PPES) and Venous Thromboembolism (VTE) in the Tabulated list of adverse reactions.

Updated on 02 June 2023

File name

6479908188e7d.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 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 26 April 2023

File name

64494c7bdce8b.pdf

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • 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 August 2022

File name

62fcf5431fd20.pdf

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data

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

Updated on 28 February 2022

File name

ADVSPCIB50IEclean_1646064421.pdf

Reasons for updating

  • Addition of joint SPC covering all presentations

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 merging of the capsules SPC with the tablets SPC

Updated on 23 July 2021

File name

DEC202149263_ADV SPC IB CAPS 16_2 IE (clean)_1627042525.pdf

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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • 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 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text
  • Removal of Black Inverted Triangle

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

Free text change information supplied by the pharmaceutical company

Please note that IBRANCE is no longer subject to additional monitoring and therefore the inverted black triangle has been removed from the SPC, PIL and IE & NI PI.

The Northern Ireland capsules and tablets SPCs and the Irish capsules SPC have been updated as follows:

- the inverted black triangle has been removed

- Section 4.2 and 4.4: editorial changes and use of passive voice to align with existing text

- Section 4.6: correction of contraception subtitle

- Section 4.8, 5.1, 5.2: editorial changes

- Section 4.8 (IE only): correction of adverse reactions reporting details

- Section 9: addition of renewal date

- Section 10: update of revision date and reference

The Irish tablets SPC has been brought in line with the EU Annex in preparation for the upcoming launch of Ibrance tablets presentation in Ireland. This SPC is included as a GDMS link, but it is not attached to this notification because it should not yet be uploaded to medicines.ie website.

Updated on 23 July 2021

File name

DEC202149263_Adv PIL IB CAPS 16_3 IE NI (clean)_1627042216.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - driving and using machines
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision
  • Removal of Black Inverted Triangle

Free text change information supplied by the pharmaceutical company

change to marketing authorisation holder - only local representative

Updated on 26 May 2021

File name

ADV SPC IB CAPS 15_2 IE (clean)_1622035337.pdf

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)

Updated on 26 May 2021

File name

Adv PIL IB CAPS 15_2 IE (clean)_1622035244.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 26 May 2021

File name

DEC202135304_Reg PIL DA 21_4 cream IE (clean)_1622035149.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 25 May 2021

File name

DEC202134894_ADV SPC IB CAPS 15_1 IE (clean)_1621940365.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Updated on 06 January 2021

File name

ADV PIL IB 14_1 IE clean_1609946263.pdf

Reasons for updating

  • Change to section 6 - what the product contains

Updated on 12 November 2020

File name

DEC202074602_ADV SPC IB 14_0 IE clean_1605185289.pdf

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 12 November 2020

File name

DEC202074602_ADV PIL IB 14_0 IE clean_1605185232.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - date of revision

Updated on 30 June 2020

File name

DEC202043777_ADV SPC IB 13_0 IE-clean_1593512012.pdf

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

File name

DEC202011341_ADV SPC IB 12_0 IE-clean_1582185078.pdf

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

File name

DEC201969108_ADV SPC IB 11_0 IE clean_1576060597.pdf

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

File name

DEC201969108_ADV PIL IB 12_0 UK IE clean_1576060547.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 22 November 2019

File name

DEC201965479_ADV PIL IB 11_0 UK IE_clean_1574435039.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 22 November 2019

File name

DEC201965479_ADV SPC IB 10_0 IE_clean_1574434975.pdf

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

File name

DEC201965234_ADV PIL IB 11_0 UK IE_clean_1574434861.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 18 November 2019

File name

DEC201964163_ADV PIL IB 10_0 UK IE clean_1574085646.pdf

Reasons for updating

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

Updated on 15 July 2019

File name

DEC201936547_ADV SPC IB 9_0 IE-clean_1563184271.pdf

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

File name

DEC201915576_ADV PIL IB 9_0 UK IE_1553766758.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 28 March 2019

File name

DEC201915576_ADV SPC IB 8_0 IE_1553766823.pdf

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

File name

ADV PIL IB 8_1 UK IE clean (003)_1550145529.pdf

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

File name

ADV PIL IB 7_0 UK IE clean_1547452304.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 14 January 2019

File name

ADV SPC IB 7_0 IE_clean_1547452432.pdf

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 07 September 2018

File name

ADV PIL IB 7_0 UK IE clean_1536316035.pdf

Reasons for updating

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

Updated on 03 August 2018

File name

ADV SPC IB 6_0 UK clean_1533295813.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 03 August 2018

File name

Reg SPC AE 23_2 50mg IE clean_1533295341.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 08 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 08 February 2018

File name

PIL_17062_41.pdf

Reasons for updating

  • New PIL for new product

Updated on 08 February 2018

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 08 February 2018

Reasons for updating

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

Updated on 30 January 2018

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

Reasons for updating

  • Change to section 6 - date of revision

Updated on 18 January 2018

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

Reasons for updating

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

Updated on 05 April 2017

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 04 April 2017

Reasons for updating

  • Change to section 6 - date of revision

Updated on 20 January 2017

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

Reasons for updating

  • New PIL for new product