Afinitor Tablets
- Name:
Afinitor Tablets
- Company:
Novartis Ireland Limited
- 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: 01/05/20
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Novartis Ireland Limited
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 1 May 2020 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Updated on 28 June 2019 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to name of medicinal product
Updated on 18 April 2019 SmPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 6.1 - List of excipients
- 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 3 April 2019 SmPC
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)
Updated on 28 January 2019 SmPC
Reasons for updating
- Other
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 12 November 2018 SmPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 15 October 2018 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 29 May 2018 SmPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 16 October 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 16 October 2017 PIL
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 28 August 2017 SmPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- 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
Section 4.6 has been updated with new information on breast-feeding based on pre-clinical data.
Section 9 has been revised to correct the last date of renewal.
Updated on 28 August 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 25 July 2016 PIL
Reasons for updating
- Change to, or new use for medicine
- Change to side-effects
- Change to drug interactions
- Change to date of revision
Updated on 3 June 2016 SmPC
Reasons for updating
- Change to section 10 - Date of revision of the text
- Change to section 4.1 - Therapeutic indications
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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
Other sections updated to reflect corresponding data.
Updated on 17 September 2015 PIL
Reasons for updating
- Change to date of revision
- Change to MA holder contact details
Updated on 1 May 2015 PIL
Reasons for updating
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 9 April 2015 SmPC
Reasons for updating
- Change to section 5 - Pharmacological properties
- Change to section 7 - Marketing authorisation holder
- 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
Following disease progression or after study unblinding, 172 of the 203 patients (84.7%) initially randomised to placebo crossed over to open-label Afinitor. The median duration of open-label treatment was 47.7 weeks among all patients; 67.1 weeks in the 53 patients randomised to everolimus who switched to open-label everolimus and 44.1 weeks in the 172 patients randomised to placebo who switched to open-label everolimus.
Also, "Median overall survival (months) (95% CI)" data included in table.
Section 7 updated to reflect new MAH address.
Updated on 23 March 2015 SmPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- 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
Updated on 27 January 2015 PIL
Reasons for updating
- Change to warnings or special precautions for use
Updated on 3 July 2014 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 4.5 - 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 6.5 - Nature and contents of container
- Change to section 8 - MA number
- Change to section 9 - Date of renewal of authorisation
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.4: Change Afinitor to Everolimus. The following paragraph has been added after Hypersensitivity.
Concomitant use of angiotensin-converting enzyme (ACE) inhibitors..........................................
Section 4.5 has been updated with a paragraph above Vaccinations....Concomitant use of angiotensin-converting enzyme (ACE) inhibitors...............................................................................
Section 4.7 has been updated re. driving and using machinery
Section 4.8 has been updated with minor changes in the paragraph titles
Section 5.2 Afinitor changed to everolimus
Section 6.5 Pack size of 60 has been deleted for 5mg and 10mg
Section 9 - Date of latest renewal has been included
Updated on 18 March 2014 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
Updated on 19 February 2014 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 8 January 2014 SmPC
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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
Update to Section 4.8 to include more information on sfatey reporting.
Updated on 27 November 2013 PIL
Reasons for updating
- Addition of joint PIL covering all presentations
Updated on 10 July 2013 SmPC
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 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- 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
Updated on 17 May 2013 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 21 January 2013 SmPC
Reasons for updating
- New individual SPC (was previously included in combined SPC)
Legal category: Product subject to medical prescription which may not be renewed (A)