Simulect 20mg powder for solution for injection or infusion
*Company:
Novartis Ireland LimitedStatus:
No Recent UpdateLegal 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 4.8, 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
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
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
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)