GAMMAGARD S/D Human Normal Immunoglobulin for Intravenous Administration Powder and solvent for solution for infusion *
Company:
Takeda Products Ireland LtdStatus:
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
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
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