Simulect 20mg powder and solvent for solution for injection or infusion

  • Name:

    Simulect 20mg powder and solvent for solution for injection or infusion

  • Company:
    info
  • Active Ingredients:

    Basiliximab

  • Legal Category:

    Product subject to restricted prescription (C)

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: 9/4/2019

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Novartis Ireland Limited

Novartis Ireland Limited

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1 - 0 of 114 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 9 April 2019 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category: Product subject to restricted prescription (C)

Updated on 8 April 2019 SmPC

Reasons for updating

  • File format updated to PDF

Legal category: Product subject to restricted prescription (C)

Updated on 23 January 2019 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 21 July 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 21 July 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 20 April 2017 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

In Section 4.4 Special Warnings and precautions for use, BK Virus has been added under Neoplasms and infections

In Section 4.8, wording has been added on how to report side effect

Updated on 20 April 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to restricted prescription (C)

Updated on 1 May 2015 PIL

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 5 January 2015 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Section 7 revised to change address of MAH

Updated on 22 September 2014 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Section 4.4 of SmPC updated to include the following text:

Use in heart transplantation

The efficacy and safety of Simulect for the prophylaxis of acute rejection in recipients of solid organ allografts other than renal have not been demonstrated. In several small clinical trials in heart transplant recipients, serious cardiac adverse events such as cardiac arrest (2.2%), atrial flutter (1.9%) and palpitations (1.4%) have been reported more frequently with Simulect than with other induction agents.

Updated on 28 April 2014 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 22 May 2012 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Update of section 4.4 of the SPC to add a cautionary statement regarding the use of live and attenuated vaccines in immunosuppressed patients and to revise the existing warning of hypersensitivity reactions as well as neoplasms and infections. Furthermore, section 4.8 is updated based on post-marketing experience.

 

Updated on 22 May 2012 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 14 December 2011 PIL

Reasons for updating

  • Change to dosage and administration

Updated on 28 July 2009 PIL

Reasons for updating

  • Change to date of revision
  • Change to improve clarity and readability

Updated on 13 November 2008 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 5 - Pharmacological properties
  • Change to section 6 - Pharmaceutical particulars
  • Change to section 4 - Clinical particulars

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

2 Inclusion of API description & origin
4.1 Inclusion of paediatric age range
4.2 Text clarifications
4.3text clarifications
4.4 Inclusion of warning using immunosuppressive combinations increasing the susceptibility to infection and warning in 4.2 that simulect must not be used unless a patient is certain to receive a graft is included here.
4.5 trade name replaced by generic name
4.6 text clarified
4.8 trade name replaced with generic name. Frequency of post marketing adverse reactions deleted.
5.1 5.2 trade replaced with generic name
6.1 headings included
6.3 text clarified
6.5 addl information on type of glass is deleted
6.6 additional precaution inspecting reconstituted samples and statement on disposal included

Updated on 17 April 2007 PIL

Reasons for updating

  • Change to date of revision

Updated on 25 August 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 26 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to restricted prescription (C)