GAMMAGARD S/D Human Normal Immunoglobulin for Intravenous Administration Powder and solvent for solution for infusion
- Name:
GAMMAGARD S/D Human Normal Immunoglobulin for Intravenous Administration Powder and solvent for solution for infusion
- Company:
Shire Pharmaceuticals Limited
- 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: 15/02/16
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Shire Pharmaceuticals Limited
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 13 November 2019
Reasons for updating
- Change to section 4.8 - Undesirable effects
Free text change information supplied by the pharmaceutical company
Updated on 12 January 2017 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
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 SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 15 February 2016 PIL
Reasons for updating
- New PIL for new product
Updated on 12 February 2016 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may not be renewed (A)