Inlyta 1mg, 3mg, 5mg & 7mg film-coated tablets
*Company:
Pfizer Healthcare IrelandStatus:
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 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- Individual PILs superseded by joint PIL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