Talzenna 0.25mg and 1mg Hard Capsules
*Company:
Pfizer Healthcare IrelandStatus:
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 24 April 2024
File name
ADVSPCTE80IEclean.pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.3 - Shelf life
- 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)
Updated on 24 April 2024
File name
ADVPILTE70IENIclean.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 3 - how to take/use
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
- Removal of Black Inverted Triangle
Updated on 22 April 2024
File name
ADV SPC TE 8_0 IEclean.pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.3 - Shelf life
- 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)
Updated on 22 April 2024
File name
ADV PIL TE 7_0 IE NIclean.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 3 - how to take/use
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
- Removal of Black Inverted Triangle
Updated on 11 January 2024
File name
ADVSPCTE70IEclean.pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.1 - List of excipients
- Change to section 6.3 - Shelf life
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - Marketing authorisation number(s)
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:
1, 2, 3, 4.1, 4.2, 4.4, 4.5, 4.7, 4.8, 5.1, 5.2, 6.1, 6.3, 6.5, and 8. Change is to add 0.1 mg capsule and new indication for metastatic castration resistant prostate cancer.
Updated on 11 January 2024
File name
ADVPILTE60IENIclean.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 14 February 2023
File name
ADV SPC TE 6_0 IE clean.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 December 2021
File name
ADV SPC TE 6_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 22 November 2021
File name
ADV SPC TE 5_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 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)
Free text change information supplied by the pharmaceutical company
SPC IE and SPC NI has been updated as follows:
4.2 – minor administrative adjustment, 4.4 – MDS/AML reporting rate updates in line with CDS, 5.1 – updated ATC code to L01XK04, 10 – revision dated updated
Updated on 22 November 2021
File name
ADV PIL TE 5_0 IE NI clean.pdf
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 September 2021
File name
DEC202163721_ADV PIL TE 4_0 IE NI clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 03 June 2021
File name
DEC202137014_ADV SPC TE 4_0 IE-clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 5.2 - Pharmacokinetic 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 12 November 2020
File name
DEC202070972_ADV SPC TE 3_0 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 12 November 2020
File name
DEC202070972_ADV PIL TE 3_0 IE clean.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 21 August 2020
File name
DEC202055395_ADV SPC TE 2_0 IE clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 August 2020
File name
DEC202055395_ADV SPC TE 2_0 IE clean.
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 5.2 - Pharmacokinetic properties
- 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:
Sections 4.2, 4.5, 5.2 have been updated with dosing information in relation to renal impairment and DDI
Please note there are also track changes marked in section 6.3. This change is to increase the shelf-life from 2 years to 3 years. The details of these changes are given on SCC decision notification DEC202055133.
Updated on 20 August 2020
File name
DEC202055395_ADV PIL TE 2_0 IE clean.pdf
Reasons for updating
- Change to section 6 - date of revision
- Product/presentation re-marketed
Updated on 09 July 2020
File name
ADV SPC TE 1_0 IE.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
New Product - Launched 15 July 2020
Updated on 09 July 2020
File name
ADV PIL TE 1_0 IE amended.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
New Products - Launched 15 July 2020