Inlyta 1mg, 3mg, 5mg & 7mg film-coated tablets
*Company:
Pfizer Healthcare Ireland Unlimited CompanyStatus:
No Recent UpdateLegal 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 16 January 2025
File name
Adv PIL IL 15_0 IE clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
- Change to other sources of information section
- Company name change or merger
- Correction of spelling/typing errors
Free text change information supplied by the pharmaceutical company
The PIL has been updated with the new address for the Freiburg manufacturer, the LENC for the LR in Ireland and removal of UK(NI) details as per latest QRD template v10.4.
Updated on 16 January 2025
File name
Adv SPC IL 14_0 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)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows: section 10 to align with the latest QRD template v10.4.
Updated on 13 February 2023
File name
DEC202157000_Adv SPC IL 13_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 08 November 2021
File name
Adv PIL IL 14_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
- Individual PILs superseded by joint PIL
Updated on 20 August 2021
File name
DEC202157000_Adv SPC IL 13_0 IE clean.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic 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: Section 5.1 ATC code has been updated in line with WHO updates to ATC/DDD index to L01EK01.
Updated on 03 November 2020
File name
DEC202073347_Adv SPC IL 12_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)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows: Update of section 4.4 of the SmPC to add text for sodium excipient to indicate contains less than 1 mmol (23 mg) sodium per film-coated tablet, that is to say essentially ‘sodium-free’.
Updated on 03 November 2020
File name
DEC202073347_Adv PIL IL 13_0 IE clean.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 4 - how to report a side effect
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 28 October 2020
File name
Adv PIL IL 12_0 IE clear.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to MA holder contact details
Updated on 18 November 2019
File name
Adv SPC IL 11_1 tabs 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 18 November 2019
File name
Adv PIL IL 11_1 UK & IE clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 15 November 2019
File name
DEC201963522_Adv SPC IL 10_0 tabs 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
The SPC has been updated as follows: Sections 4.8 to add the adverse reaction cholecystitis with frequency ‘common’.
Updated on 15 November 2019
File name
DEC201963522_Adv PIL IL 10_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
- Change to other sources of information section
- Change to MA holder contact details
Updated on 10 October 2019
File name
DEC201956080_Adv SPC IL 10_0 tabs IE clean.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: Sections 4.4 and 4.8 to update wording on the use of VEGF inhibitors and formation artery dissections and aneurysms.
Updated on 10 October 2019
File name
DEC201956080_Adv PIL IL 10_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
- Change to other sources of information section
- Change to MA holder contact details
Updated on 28 November 2018
File name
Adv PIL IL 9_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 28 November 2018
File name
Adv SPC IL 9_0 tabs IE clean.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:
Update of sections 4.4 and 4.8 of the SmPC to add a warning on the risk of aneurysm rupture and to add the new ADR ‘aneurysm rupture’ as an example of bleeding in a footnote under the table of adverse reactions.
Updated on 09 August 2018
File name
Adv PIL IL 8_0 UK & IE clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
- Change to MA holder contact details
Updated on 09 August 2018
File name
Adv SPC IL 8_0 tabs IE clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- 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 the MAH, Section 9 addition of renewal date and Section 10 date of revision of the text. - Brexit MA transfer from Pfizer Limited to Pfizer Europe MA EEIG
Updated on 27 June 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 June 2017
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 4.7 - 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 9 - Date of first authorisation/renewal of the authorisation
- 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:
SPC sections: 4.2, 4.4, 4.7, 4.8, 5.1, 5.2, 6.1, 9 and 10.No black triangle
Updated on 27 June 2017
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 4.7 - 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 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
SPC sections: 4.2, 4.4, 4.7, 4.8, 5.1, 5.2, 6.1, 9 and 10.No black triangle
Updated on 16 June 2017
File name
PIL_15657_594.pdf
Reasons for updating
- New PIL for new product
Updated on 13 June 2016
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)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
To update section 4.4 of the SmPC to implement the PRAC signal recommendations on ‘Nephrotic syndrome.’Updated on 13 June 2016
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
To update section 4.4 of the SmPC to implement the PRAC signal recommendations on ‘Nephrotic syndrome.’Updated on 22 June 2015
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
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 – Editorial changes, Grade 4 severity proteinuria added; Section 4.8 – ADRs and ADR frequencies updated based on a pooled analysis (n=672 patients) of clinical safety data from the 5 RCC studies; update to HPRA reporting details (IE only)
Updated on 22 June 2015
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Section 4.4 – Editorial changes, Grade 4 severity proteinuria added; Section 4.8 – ADRs and ADR frequencies updated based on a pooled analysis (n=672 patients) of clinical safety data from the 5 RCC studies; update to HPRA reporting details (IE only)
Updated on 30 June 2014
Reasons for updating
- Change to section 3 - Pharmaceutical form
- 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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.2 - Incompatibilities
- 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
Updates to:
Sections 3, 4.2, 4.4, 4.5, 4.8, 5.1, 5.2, 6.2, 6.3Updated on 30 June 2014
Reasons for updating
- Change to section 3 - Pharmaceutical form
- 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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.2 - Incompatibilities
- Change to section 6.3 - Shelf life
Free text change information supplied by the pharmaceutical company
Updates to:
Sections 3, 4.2, 4.4, 4.5, 4.8, 5.1, 5.2, 6.2, 6.3Updated on 05 December 2013
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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
Updated on 05 December 2013
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
Free text change information supplied by the pharmaceutical company
Updated on 05 September 2013
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5 - Pharmacological properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6 - Pharmaceutical particulars
- Change to section 6.1 - List of excipients
- Change to section 8 - MA number
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 2, 3, 6.5, 8 – details regarding 3mg and 7mg added;
Section 4.2, 4.4, 5.2, 6.1 – QRD changes;
Section 4.7 - Axitinib has a minor influence on the ability to drive and use machines added;
Section 4.8 – details added regarding reporting of side effects
Updated on 05 September 2013
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5 - Pharmacological properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6 - Pharmaceutical particulars
- Change to section 6.1 - List of excipients
- Change to section 8 - MA number
Free text change information supplied by the pharmaceutical company
Section 2, 3, 6.5, 8 – details regarding 3mg and 7mg added;
Section 4.2, 4.4, 5.2, 6.1 – QRD changes;
Section 4.7 - Axitinib has a minor influence on the ability to drive and use machines added;
Section 4.8 – details added regarding reporting of side effects
Updated on 04 April 2013
Reasons for updating
- Change to 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
Updated on 04 April 2013
Reasons for updating
- Change to joint SPC covering all presentations
Free text change information supplied by the pharmaceutical company
Updated on 01 March 2013
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 01 March 2013
Reasons for updating
- New SPC for new product
Free text change information supplied by the pharmaceutical company
Pfizer Healthcare Ireland Unlimited Company
Address:
The Watermarque Building, Ringsend Road, Dublin 4, D04 K7N3, IrelandTelephone:
+353 1 467 6500Fax:
+353 1 467 6501Website:
https://www.pfizermedicalinformation.ie/Medical Information Direct Line:
1 800 633 363