Thymoglobuline 25 mg powder for solution for infusion

  • Name:

    Thymoglobuline 25 mg powder for solution for infusion

  • Company:
    info
  • Active Ingredients:

    Rabbit Anti-Human Thymocyte Immunoglobulin

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 05/07/19

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Summary of Product Characteristics last updated on medicines.ie: 5/7/2019

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Sanofi Genzyme

Sanofi Genzyme logo_1556886599

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Medicine Name Myozyme 50 mg, powder for concentrate for solution for infusion. Active Ingredients Alglucosidase alfa
Medicine Name Thymoglobuline 25 mg powder for solution for infusion Active Ingredients Rabbit Anti-Human Thymocyte Immunoglobulin
Medicine Name Thyrogen 0.9 mg powder for solution for injection Active Ingredients Thyrotropin alfa
1 - 0 of 19 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 5 July 2019 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect

Updated on 5 July 2019 SmPC

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 SmPC

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

  • New PIL for new product

Updated on 25 August 2016 PIL

Reasons for updating

  • Change to date of revision

Updated on 2 August 2016 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 2 August 2016 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 medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Tabulated list of adverse reactions added

Updated on 14 July 2016 PIL

Reasons for updating

  • Change to side-effects

Updated on 3 July 2015 SmPC

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

The SmPC has been updated in line with the latest Quality Review Document, making minor corrections through the document, such as changing the word 'drugs' to 'medicinal product' and changes to section headings.

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 SmPC

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

Sections 4.4 & 4.8 updated in line with the PSUR worksharing

Updated on 29 April 2010 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 28 April 2010 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

None provided