Myfortic 180 mg gastro-resistant tablets

*
Pharmacy Only: Prescription
  • Company:

    Novartis Ireland Limited
  • Status:

    Updated
  • Legal 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_180mg_PIL PF23-0193__clean_01 2024.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 16 May 2024

File name

Myfortic-180mg 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)

EDM Updated on 31 July 2023

File name

IE_Guide for patients_Myfortic_RMP V2.1 Clean.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 31 July 2023

File name

IE_Guide for HCP _Myfortic_RMP V2.1 Clean.pdf

Reasons for updating

  • Add New Doc

Updated on 31 January 2023

File name

Myfortic 180mg REGPIL PF22-0018 Clean Jan 2023.pdf

Reasons for updating

  • Change to section 2 - driving and using machines

Updated on 31 January 2023

File name

Myfortic 180mg 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 19 September 2022

File name

Myfortic 180mg 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 180 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 180 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 180 mg-REGPIL PF 21-0192.pdf

Reasons for updating

  • Change to section 2 - excipient warnings

Updated on 24 March 2021

File name

Myfortic 180mg REGSPC_PF20-0192_Clean_January 2021.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 28 November 2019

File name

PIL Myfortic 180mg_Clean_PF 19-0147 Sep 2019 IPHA.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 22 March 2019

File name

Myfortic 180mg 46243666_IE_p2_LFT_X-4 RA approved 12.03.2019_IPHA.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect

Updated on 22 January 2019

File name

Myfortic 180mg 2218871_IE_WEH_p2_LFT_X-4 RA approved 03.01.2019_IPHA.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 04 December 2018

File name

PIL_14222_47.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 180mg_ 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 180mg 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_14222_47.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 information about pregnancy or lactation
  • Change to date of revision

Updated on 07 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

  • New PIL for medicines.ie