Neoral 100mg/ml concentrate for oral solution

  • Name:

    Neoral 100mg/ml concentrate for oral solution

  • Company:
    info
  • Active Ingredients:

    Ciclosporin

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 23/01/19

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Summary of Product Characteristics last updated on medicines.ie: 9/8/2018

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Novartis Ireland Limited

Novartis Ireland Limited

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1 - 0 of 116 items.Total: Infinity pages

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 23 January 2019 PIL

Reasons for updating

  • New PIL for medicines.ie
  • Change to section 6 - marketing authorisation holder

Updated on 9 August 2018 SmPC

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 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 24 September 2015 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 24 September 2015 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 clarify the wording in "posology and method of administration".

Updated on 4 March 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 4 March 2015 SmPC

Reasons for updating

  • 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 4.8 has been updated to include the following:

Pain of lower extremities

Isolated cases of pain of lower extremities have been reported in association with ciclosporin. Pain of lower extremities has also been noted as part of Calcineurin-Inhibitor Induced Pain Syndrome (CIPS).

Updated on 4 March 2015 PIL

Reasons for updating

  • Change to side-effects

Updated on 29 September 2014 SmPC

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

Entire SmPC revised following approval of Article 30 referral resulting in harmonisation across all EU countries.

Updated on 11 August 2014 PIL

Reasons for updating

  • Change due to harmonisation of PIL

Updated on 13 February 2013 PIL

Reasons for updating

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

Updated on 26 November 2012 SmPC

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 a paragraph about the conversion between oral ciclosporin formulations.

 

Section 4.4 and Section 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 been updated to include a sentence about the use of ciclosporin in liver transplant patients HCV+ and HCV-.

Updated on 13 September 2012 SmPC

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 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • 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

Following licence renewal, numerous changes were required to the SmPC after IMB assessment.

Updated on 29 August 2012 PIL

Reasons for updating

  • Change of manufacturer

Updated on 29 July 2011 PIL

Reasons for updating

  • Change to date of revision

Updated on 17 April 2007 PIL

Reasons for updating

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

Updated on 14 December 2006 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 5.1 - Pharmacodynamic 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

Section 4.1 - 4.6 and 5.1, 5.3. Update were made to align the National Prescribing Informtion with the Company Core Data Sheet.

Updated on 22 May 2006 SmPC

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 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 16 May 2005 SmPC

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 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 2 July 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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