IBRANCE 75mg, 100mg & 125mg hard capsules
*Company:
Pfizer Healthcare Ireland Unlimited CompanyStatus:
UpdatedLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 02 December 2024
File name
Adv PIL IB CAPS 20_0 IE NI (clean).pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Updated on 14 November 2024
File name
ADV SPC IB 11_1 IE (clean).pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - 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:
Updated Sections 4.2, 4.8, 5.1 and 5.2 with useful information to healthcare providers on palbociclib in combination with chemotherapy for the safety, pharmacokinetics, and efficacy in the paediatric patient population (based on final results from study A5481092).
Updated on 22 May 2024
File name
clean ADV SPC IB 10_0 IE.pdf
Reasons for updating
- 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 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 and SPC NI has been updated as follows:
Section 4.5 inclusion of drug-drug interactions between Palbociclib and statins which may increase the risk of rhabdomyolysis due to increased statin plasma concentration. Section 4.8 was updated to includea common ADR, blood creatinine increase. Section 10 was updated to reflect the date of text revision.
Updated on 22 May 2024
File name
clean Adv PIL IB CAPS 19_0 IE NI.pdf
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 - date of revision
Updated on 09 May 2024
File name
clean ADV SPC IB 9_0 IE.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 09 May 2024
File name
clean ADV PIL IB CAPS 18_0 IE NI.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 02 June 2023
File name
ADVSPCIB80IEclean.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
AdvPILIBCAPS170IENIclean.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
ADV SPC IB 7_1 IE clean.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
ADVSPCIB61IEclean.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.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).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.
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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).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).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).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).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).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.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.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.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.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.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
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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
File name
DEC201969108_ADV SPC IB 11_0 IE clean.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.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.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.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
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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
File name
DEC201965234_ADV PIL IB 11_0 UK IE_clean.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.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.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.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.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).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.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.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
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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 07 September 2018
File name
ADV PIL IB 7_0 UK IE clean.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.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.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.
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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 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
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
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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
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
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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 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
Updated on 19 January 2017
Reasons for updating
- New PIL for new product