IBRANCE 75 mg 100mg & 125mg hard capsules
- Name:
IBRANCE 75 mg 100mg & 125mg hard capsules
- Company:
Pfizer Healthcare Ireland
- Active Ingredients:
- 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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Pfizer Healthcare Ireland
Company Products
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 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
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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.
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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
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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
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The SPC has been updated as follows:
Section 4.2 - Posology - editorial update to include instructions in aromatase inhibitors. |
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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.
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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
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
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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
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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
Updated on 19 January 2017 PIL
Reasons for updating
- New PIL for new product