Simulect 20mg powder for solution for injection or infusion

  • Company:

    Novartis Ireland Limited
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to restricted prescription (C)
  • Active Ingredient(s):

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

Updated on 19 December 2023

File name

Simulect REG PIL PF23-0178-IB-116_Clean_09.10.2023.pdf

Reasons for updating

  • Product/presentation re-marketed

Updated on 19 October 2023

File name

Simulect_REG SPC_PF23-0178_Oct 2023_clean.pdf

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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 8 - Marketing authorisation number(s)

Legal category:Product subject to restricted prescription (C)

Updated on 19 January 2022

File name

Simulect 20mg PIL IPHA 09.2021.pdf

Reasons for updating

  • Change to name of manufacturer

Updated on 08 January 2021

File name

Simulect 20mg REGSPC PF 21-0002 Dec 2020_Clean.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.6 - Special precautions for disposal and other handling

Legal category:Product subject to restricted prescription (C)

Updated on 08 January 2021

File name

Simulect_20mg_PowdrnSolvt_Soln_Inj_Inf REGPIL PF 21-0002_14-Dec-20_English_Clean.pdf

Reasons for updating

  • Change to section 2 - excipient warnings

Updated on 12 October 2020

File name

Simulect 20mg PIL PF 20-0077_Clean_March 2020 IPHA.pdf

Reasons for updating

  • Change of manufacturer

Updated on 09 April 2019

File name

Simulect__20mg_REGSPC_Clean.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Product subject to restricted prescription (C)

Updated on 08 April 2019

File name

Simulect 20mg REGSPC_April 2017__IPHA.pdf

Reasons for updating

  • File format updated to PDF

Legal category:Product subject to restricted prescription (C)

Updated on 23 January 2019

File name

Simulect 20mg Package leaflet IPHA.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 21 July 2017

File name

PIL_8527_751.pdf

Reasons for updating

  • New PIL for new product

Updated on 21 July 2017

Reasons for updating

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

Updated on 20 April 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to restricted prescription (C)

Updated on 20 April 2017

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 01 May 2015

Reasons for updating

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

Updated on 05 January 2015

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

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

Reasons for updating

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

Updated on 22 May 2012

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

Reasons for updating

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

Updated on 14 December 2011

Reasons for updating

  • Change to dosage and administration

Updated on 28 July 2009

Reasons for updating

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

Updated on 13 November 2008

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

Reasons for updating

  • Change to date of revision

Updated on 25 August 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 26 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to restricted prescription (C)