Thymoglobuline 25 mg powder for solution for infusion
*Company:
Sanofi GenzymeStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 27 October 2023
File name
1.3.2.1 Mock-up - Package Leaflet (PIL) Thymoglobuline (5).pdf
Reasons for updating
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - manufacturer
Updated on 27 October 2023
File name
1.3.1.1 Summary of Product Characteristics (SmPC) Thymoglobuline - Ireland.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 October 2023
File name
1.3.2.1 Mock-up - Package Leaflet (PIL) Thymoglobuline (5).pdf
Reasons for updating
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - manufacturer
Updated on 05 September 2023
File name
1.3.2.1 Mock-up - Package Leaflet (PIL) Thymoglobuline (2).pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - manufacturer
Updated on 05 September 2023
File name
1.3.1.1 Summary of Product Characteristics (SmPC) Thymoglobuline - Ireland.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 31 July 2023
File name
1.3.1.1 Summary of Product Characteristics (SmPC) Thymoglobuline (3) IE.pdf
Reasons for updating
- Previous version of SPC reinstated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 31 July 2023
File name
1.3.1.1 Summary of Product Characteristics (SmPC) Thymoglobuline (2).pdf
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 19 May 2023
File name
1.3.1.1 Summary of Product Characteristics (SmPC) Thymoglobuline (1).pdf
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 15 December 2020
File name
UK-IE-MT PILmockup IE 1209 SA 3089, SA3411 Thymoglobulin PIL 789728 (1).pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 20 November 2020
File name
1.3.1 IE1209 SmPC-iv-h-581-envar clean.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 November 2020
File name
UK-IE-MT PIL IE 1209 SA 3089 Thymoglobulin PIL 789728.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - use in children and adolescents
- 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
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 06 July 2020
File name
en-ie-mt-PIL-Thymoglobulin-PUSA Mock-up-Leaflet-2019-03-27.pdf
Reasons for updating
- XPIL Removed
Updated on 05 July 2019
File name
en-ie-mt-PIL-Thymoglobulin-PUSA Mock-up-Leaflet-2019-03-27.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
Updated on 05 July 2019
File name
1.3.1. IE 959 Thymoglobulin_SmPC_PSUSA update approved.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update of section 4.8 of the SmPCs to include “hyperbilirubinaemia” with a frequency “unknown” and “anaemia” with a frequency “very common”. The Package leaflet is updated accordingly.”
Updated on 29 January 2019
File name
Thymoglobulin PIL 740804.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 29 January 2019
File name
Thymoglobulin_SmPC_var071_G_clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 7 to reflect Waterford with MAH address
Updated on 11 January 2019
File name
PIL Mock up Thymoglobulin 25mg powder.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 25 August 2016
File name
PIL_14675_747.pdf
Reasons for updating
- New PIL for new product
Updated on 25 August 2016
Reasons for updating
- Change to date of revision
Updated on 02 August 2016
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 02 August 2016
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 medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 14 July 2016
Reasons for updating
- Change to side-effects
Updated on 03 July 2015
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.2 updated to include a separate paragraph for 'Paediatric population' (text included with elderly patients beforehand).
Section 4.8: new paragraph on 'Paediatric population' and new wording on the reporting of suspected adverse reactions included.
Section 5.2: new paragraph on 'Paediatric population'.
Updated on 24 June 2015
Reasons for updating
- Change to side-effects
- Change to further information section
- Change to date of revision
Updated on 23 April 2013
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 29 April 2010
Reasons for updating
- New PIL for medicines.ie
Updated on 28 April 2010
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)