Thymoglobuline 25 mg powder for solution for infusion
- Name:
Thymoglobuline 25 mg powder for solution for infusion
- Company:
Sanofi Genzyme
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 15/12/20
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Sanofi Genzyme
Company Products
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 15 December 2020 PIL
Reasons for updating
- Change to section 6 - manufacturer
Updated on 20 November 2020 SPC
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 PIL
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 6 July 2020 PIL
Reasons for updating
- XPIL Removed
Updated on 5 July 2019 PIL
Reasons for updating
- Change to section 4 - how to report a side effect
Updated on 5 July 2019 SPC
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 PIL
Reasons for updating
- Change to section 6 - manufacturer
Updated on 29 January 2019 SPC
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 PIL
Reasons for updating
- Improved presentation of PIL
Updated on 25 August 2016 PIL
Reasons for updating
- Change to date of revision
Updated on 25 August 2016 PIL
Reasons for updating
- New PIL for new product
Updated on 2 August 2016 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 2 August 2016 SPC
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 PIL
Reasons for updating
- Change to side-effects
Updated on 3 July 2015 SPC
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 PIL
Reasons for updating
- Change to side-effects
- Change to further information section
- Change to date of revision
Updated on 23 April 2013 SPC
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 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 28 April 2010 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may not be renewed (A)