IBRANCE 75mg, 100mg & 125mg film coated tablets
*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 TABS 8_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 TABS 7_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 TABS 6_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
ADVPILIBTABS50IENIclean.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 01 March 2022
File name
ADVSPCIB50IEclean.pdf
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
SPC now covers both Film coated tablets and capsules
Updated on 01 March 2022
File name
ADVPILIBTABS42IENIclean.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
New PIL for new dosage