Inlyta 1mg, 3mg, 5mg & 7mg film-coated tablets
- Name:
Inlyta 1mg, 3mg, 5mg & 7mg film-coated tablets
- Company:
Pfizer Healthcare Ireland
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 18/11/19
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Pfizer Healthcare Ireland
Company Products
When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Updated on 18 November 2019 SmPC
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 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 15 November 2019 SmPC
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 PIL
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 SmPC
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 PIL
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 PIL
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 SmPC
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 9 August 2018 PIL
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 9 August 2018 SmPC
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 SmPC
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 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 27 June 2017 PIL
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 PIL
Reasons for updating
- New PIL for new product
Updated on 13 June 2016 SmPC
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 PIL
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 PIL
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 22 June 2015 SmPC
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 30 June 2014 SmPC
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 PIL
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 5 December 2013 SmPC
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 5 December 2013 PIL
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 5 September 2013 PIL
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 5 September 2013 SmPC
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 4 April 2013 PIL
Reasons for updating
- Change to joint SPC covering all presentations
Free text change information supplied by the pharmaceutical company
Updated on 4 April 2013 SmPC
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 1 March 2013 PIL
Reasons for updating
- New SPC for new product
Free text change information supplied by the pharmaceutical company
Updated on 1 March 2013 SmPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)