Myfortic 360 mg gastro-resistant tablets
*Company:
Novartis Ireland LimitedStatus:
UpdatedLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 05 November 2024
File name
Myfortic_360mg_PIL_clean_PF23-0193 01 2024.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 16 May 2024
File name
Myfortic 360mg REGSPC_IA91 PF24-0030 -clean May 2024.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
Legal category:Product subject to medical prescription which may be renewed (B)
File name
IE_Guide for patients_Myfortic_RMP V2.1 Clean.pdf
Reasons for updating
- Add New Doc
File name
IE_Guide for HCP _Myfortic_RMP V2.1 Clean.pdf
Reasons for updating
- Add New Doc
Updated on 02 February 2023
File name
Myfortic 360mg REGSmPC PF22-0018 Clean Jan 2023.pdf
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.7 - Effects on ability to drive and use machines
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 31 January 2023
File name
Myfortic 360mg REGPIL PF22-0018 Clean Jan 2023.pdf
Reasons for updating
- Change to section 2 - driving and using machines
Updated on 19 September 2022
File name
Myfortic 360mg REGSPC PF 21-0172 clean July 2022.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 11 July 2022
File name
Myfortic 360 mg REGSPC PF21-0296_SL ext June 2022 clean.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 29 April 2021
File name
Myfortic 360 mg-REGSPC PF 21-0018_Clean April 2021.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 24 March 2021
File name
Myfortic 360 mg-REGPIL PF 21-0192.pdf
Reasons for updating
- Change to section 2 - excipient warnings
Updated on 28 November 2019
File name
PIL Myfortic 360mg_Clean_ PF 19-0147 Sep 2019.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 22 March 2019
File name
Myfortic 360mg 46243667_IE_p2_LFT_X-4 RA reviewed 11.03.2019_IPHA.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
Updated on 22 January 2019
File name
Myfortic 360mg 2218873_IE_WEH_p2_LFT_X-4 RA reviewed 03.01.2019 IPHA.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 04 December 2018
File name
PIL_9191_720.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 03 December 2018
File name
SmPC Myfortic 360mg_CLEAN December 2018.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 24 July 2018
File name
Myfortic 360mg REGSPC_Clean July 2018.pdf
Reasons for updating
- Change to MA holder contact details
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 15 November 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 11 May 2016
File name
PIL_9191_720.pdf
Reasons for updating
- New PIL for new product
Updated on 11 May 2016
Reasons for updating
- Change to warnings or special precautions for use
Updated on 01 May 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change to storage instructions
- Change to side-effects
- Change to information about pregnancy or lactation
- Change to date of revision
Updated on 11 February 2013
Reasons for updating
- Change to warnings or special precautions for use
Updated on 22 June 2012
Reasons for updating
- Change to warnings or special precautions for use
- Change to storage instructions
- Change to information about pregnancy or lactation
- Change to date of revision
Updated on 20 September 2011
Reasons for updating
- Change of manufacturer
Updated on 24 February 2011
Reasons for updating
- Change to side-effects
Updated on 14 April 2009
Reasons for updating
- Joint PIL superseded by PILs for individual presentations
Updated on 27 October 2006
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 01 November 2004
Reasons for updating
- New PIL for medicines.ie