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Sandimmun 100mg/ml concentrate for oral solution

*
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 oral soln_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 oral soln_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 oral soln_REG PIL_PF22-0183_09.01.2023_clean_IPHA.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 11 January 2023

File name

Sandimmun oral soln_REG SPC_PF22-0183_01.12.2022_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 30 November 2022

File name

Sandimmun oral soln_REG SPC_PF22-0133_30.11.2022_clean_IPHA.pdf

Reasons for updating

  • Change to section 6.6 - Special precautions for disposal and other handling

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

Updated on 30 November 2022

File name

Sandimmun oral soln_REG PIL_PF22-0133_30.11.2022_clean_IPHA.pdf

Reasons for updating

  • Change to section 3 - how to take/use

Updated on 30 November 2022

File name

Sandimmun oral soln_REG PIL_PF22-0077_26.07.2022_clean_IPHA.pdf

Reasons for updating

  • Change to section 3 - how to take/use

Updated on 28 July 2022

File name

Sandimmun oral soln_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 oral soln_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 25 November 2021

File name

Sandimmun Oral Soln_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 OS_REG PIL_PF 20-0200_March 2021_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

Updated on 31 March 2021

File name

Sandimmun Oral Sol_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 13 May 2020

File name

Sandimmun oral solt REG PIL PF 19-0253 March 2020 IPHA.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 19 March 2020

File name

Sandimmun 100 mgl oral sol REG PIL 5042266_IPHA.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 Concentrate for oral solution 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 08 January 2020

File name

Sandimmun 100 mgl oral sol REG PIL 5042266_IPHA.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 23 January 2019

File name

IPHA_Sandimmunoralsolt_100mgml5042266_IE__LFT_TBI20 Jan2019.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 09 August 2018

File name

REG_SPC_Sandimmun Concentrate for oral solution_PF18-0228_clean.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)

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

Updated on 10 May 2018

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_8557_660.pdf

Reasons for updating

  • New PIL for new product

Updated on 17 September 2015

Reasons for updating

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

Updated on 26 June 2015

Reasons for updating

  • New SPC for new product

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

Updated on 26 June 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 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.4 has been revised to update the sorbitol warning
Section 4.8 has been updated to include "pain of lower extremities" as an adverse event of unknown frequency.

Updated on 29 September 2014

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change due to harmonisation of SPC

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

Free text change information supplied by the pharmaceutical company

The entire SmPC has been revised after approval of Article 30 referral during which the text has been harmonised across all EU countries.

Updated on 24 September 2014

Reasons for updating

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

Updated on 21 May 2014

Reasons for updating

  • Change due to harmonisation of PIL

Updated on 13 February 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 23 November 2012

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 4.8 - 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.2 has been updated to include paragraph about conversion between oral forms of ciclosporin.

Sections 4.4 and 4.8 have been updated to specifically describe PML and BK virus nephropathy in the general statement on infections in patients receiving immunosuppressive therapies.

Section 5.1 has beeen updated to include a sentence about the use of ciclosporing in liver transplant patients HCV+ and HCV-. 


 

Updated on 24 September 2012

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

Numerous changes made to the SmPC following licence renewal assessment by the IMB.

Updated on 29 August 2012

Reasons for updating

  • Change of manufacturer

Updated on 17 April 2007

Reasons for updating

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

Updated on 17 April 2007

Reasons for updating

  • Improved electronic presentation

Updated on 26 October 2006

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data

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

Free text change information supplied by the pharmaceutical company

Changes to section 4.1(Therapeutic Indications), Section 4.2 (Posology and Method of Administration), Section 4.4 (Special Warnings and Precautions for Use) Section 4.5 (Interactions with other Medicaments and other forms of Interaction,) Section 4.6 (Pregnancy and Lactation), Section 4.8 (Undesirable Effects), Section 5.1(Pharmacodynamic Properties), Section 5.2 (Pharmacokinetic Properties) and, Section 5.3 (Preclinical Safety Data) following an update to the company core data sheet

Updated on 23 June 2006

Reasons for updating

  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

Prescribing Information updated.

Updated on 22 May 2006

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 17 May 2005

Reasons for updating

  • Change to section 10 - Date of revision of the text

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

Updated on 17 May 2005

Reasons for updating

  • Improved electronic presentation

Updated on 16 May 2005

Reasons for updating

  • Change to section 10 - Date of revision of the text

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

Updated on 26 August 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 10 August 2004

Reasons for updating

  • Change to section 5.3 - Preclinical safety data

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

Updated on 13 August 2003

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation

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

Updated on 01 July 2003

Reasons for updating

  • New SPC for medicines.ie

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