GAMMAGARD S/D Human Normal Immunoglobulin for Intravenous Administration Powder and solvent for solution for infusion *

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 13 November 2019

File name

Gammagard SPC Ireland 4 Mar 2019 - Clean_1573645403.pdf

Reasons for updating

  • 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

PRAC update to include a new ADR: lupus like syndrome.

Updated on 12 January 2017

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

In section 4.4, the warning on Aseptic Meningitis Syndrome (AMS) has been reworded

In section 4.8, the paragraph on Aseptic Meningitis Syndrome (AMS) has been reworded, the MedDRA Version has been updated and the Post-Marketing AE for Nervous System Disorders has been amended from Convulsion to Seizure

Updated on 12 January 2017

Reasons for updating

  • New SPC for new product

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

Updated on 15 February 2016

File name

PIL_16634_472.pdf

Reasons for updating

  • New PIL for new product

Updated on 12 February 2016

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