Afinitor 2.5mg, 5mg and 10mg Tablets
*Company:
Novartis Ireland LimitedStatus:
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 15 August 2022
File name
Afinitor_REG PIL_PF22-0108_24.06.2022_clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 15 August 2022
File name
Afinitor_REG SPC_PF22-0108_24.06.2022_clean.pdf
Reasons for updating
- 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 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 17 December 2021
File name
Afinitor_REG SPC_PF21-0323_Dec 2021_clean_IPHA.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 17 December 2021
File name
Afinitor REG PIL_PF21-0323_clean_IPHA.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 27 October 2021
File name
Afinitor_REG SPC_PF21-0280_Oct 2021_clean_IPHA.pdf.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 09 July 2021
File name
Afinitor_REG PIL_2.5mg_10mg_5mg_Tab_17-Jun-21_Clean.pdf
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 4 - possible side effects
- Change to section 6 - manufacturer
Updated on 09 July 2021
File name
Afinitor_REG SPC_PF21-0155_17.06.2021_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)
Updated on 29 June 2021
File name
Afinitor_REG SPC_PF21-0155_17.06.2021_clean.pdf
Reasons for updating
- 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 02 November 2020
File name
Afinitor_10mg_2.5mg_5mg REGPIL_Tab__PF20-0212_IPHA.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
Updated on 23 June 2020
File name
Afinitor Tabs REGSPC PF 20-0121_June 2020 Clean.pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 01 May 2020
File name
Afinitor_10mg_2.5mg_5mg REGPIL_Tab__Clean Feb 2020.pdf
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
File name
REG PIL_Afinitor_10mg_2.5mg_5mg_Tab_PF19-0089_Clean_IPHA.pdf
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
File name
Afinitor_REG SPC_PF 19-0089_IPHA.pdf
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 03 April 2019
File name
Afinitor REG SPC_PF 18-0273_corrected_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)
Updated on 28 January 2019
File name
Afinitor REG SPC_PF 18-0273_clean_IPHA.pdf
Reasons for updating
- Other
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 12 November 2018
File name
Afinitor REG SPC_PF 18-0273_clean.pdf
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
File name
Afinitor Tablets REG PIL_2212802_R91_IPHA.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 29 May 2018
File name
Afinitor_REG_SPC_PF_18-0120_clean.docx
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
File name
PIL_15742_903.pdf
Reasons for updating
- New PIL for new product
Updated on 16 October 2017
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
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 28 August 2017
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 25 July 2016
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 03 June 2016
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
Reasons for updating
- Change to date of revision
- Change to MA holder contact details
Updated on 01 May 2015
Reasons for updating
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 09 April 2015
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
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
Reasons for updating
- Change to warnings or special precautions for use
Updated on 03 July 2014
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
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
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 08 January 2014
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
Reasons for updating
- Addition of joint PIL covering all presentations
Updated on 10 July 2013
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
Reasons for updating
- New PIL for medicines.ie
Updated on 21 January 2013
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)