Sandimmun 100mg Soft Capsules

Product Information *

  • Company:

    Novartis Ireland Limited
  • Status:

    No Recent Update
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

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

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 31 March 2021

File name

Sandimmun 100mg SC_REG SPC_PF 20-0200_March 2021_IPHA_1617187868.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
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage

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

Updated on 31 March 2021

File name

Sandimmun SC_REG PIL_PF 20-0200_Clean_1617187748.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product looks like and pack contents

Updated on 19 March 2020

File name

Sandimmun CapsREG PIL PF 19-0253 March 2020_1584613001.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - how to report a side effect

Updated on 19 March 2020

File name

Sandimmun 100mg Soft Capsules REG SPC PF19-0253 March 2020 clean_1584612946.pdf

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

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

Updated on 03 January 2020

File name

Sandimmun Soft Capsules REG PIL 46238042 August 2018_IPHA_1578061254.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 23 January 2019

File name

IPHA_sandimmunscapsulesPIL_46238042_IE_REG REV TBI 6 Jan 2019_1548258351.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 09 August 2018

File name

REG_SPC_Sandimmun 100mg Soft Capsules_PF18-0228_clean_1533812301.pdf

Reasons for updating

  • New SPC for new product

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

Updated on 17 September 2015

File name

PIL_8556_391.pdf

Reasons for updating

  • New PIL for new product

Updated on 17 September 2015

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 24 September 2014

Reasons for updating

  • Change to date of revision
  • Change due to harmonisation of PIL

Updated on 08 January 2013

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 17 April 2007

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 17 May 2005

Reasons for updating

  • Improved electronic presentation

Updated on 26 August 2004

Reasons for updating

  • New PIL for medicines.ie