Inlyta 1mg, 3mg, 5mg & 7mg film-coated tablets *
Pharmacy Only: Prescription

  • Company:

    Pfizer Healthcare Ireland
  • Status:

    No Recent Update
  • Legal 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 08 November 2021

File name

Adv PIL IL 14_0 IE NI clean_1636392045.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  • Individual PILs superseded by joint PIL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_1629473456.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_1604386863.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_1604386809.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_1603895385.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_1574096002.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_1574095958.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_1573831235.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_1573831142.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_1570698457.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_1570698395.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_1543418495.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_1543418633.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_1533805324.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_1533805413.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, 6.3

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

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, 6.3

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

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update to sections 4.2 & 4.8

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

Update to sections 4.2 & 4.8

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

Individual SPCs  changed to joint SPC of 1mg & 5mg.

Updated on 04 April 2013

Reasons for updating

  • Change to joint SPC covering all presentations

Free text change information supplied by the pharmaceutical company

Individual SPCs  changed to joint SPC of 1mg & 5mg.

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

None provided

Updated on 01 March 2013

Reasons for updating

  • New SPC for new product

Free text change information supplied by the pharmaceutical company

None provided