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Sandimmun 100mg Soft Capsules

*
Pharmacy Only: Prescription

  • Company:

    Novartis Ireland Limited

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Ciclosporin

    *Additional information is available within the SPC or upon request to the company

Updated on 20 June 2023

File name

Sandimmun 100mg capsules_REG SPC_PF22-0134_08.06.2023_clean_IPHA.pdf

Reasons for updating

  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 5.3 - Preclinical safety data

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

Updated on 20 June 2023

File name

Sandimmun capsules_REG PIL_PF22-0134_08.06.2023_clean_IPHA.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines

Updated on 11 January 2023

File name

Sandimmun 100mg capsules_REG SPC_PF22-0183_09.01.2023_clean_IPHA.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 January 2023

File name

Sandimmun capsules_REG PIL_PF22-0183_09.01.2023_clean_IPHA.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 28 July 2022

File name

Sandimmun 100mg capsules_REG SPC_PF22-0077_26.07.2022_clean_IPHA.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

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

Updated on 28 July 2022

File name

Sandimmun capsules_REG PIL_PF22-0077_26.07.2022_clean_IPHA.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink

Updated on 21 December 2021

File name

Sandimmun SC_REG PIL_PF21-0206_Nov 2021_clean_typo corrected.pdf

Reasons for updating

  • Correction of spelling/typing errors

Updated on 25 November 2021

File name

Sandimmun SC_REG PIL_PF21-0206_Nov 2021_clean.pdf

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents

Updated on 31 March 2021

File name

Sandimmun 100mg SC_REG SPC_PF 20-0200_March 2021_IPHA.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.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.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.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.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.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.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