Atgam 50 mg/ml concentrate for solution for infusion
*Company:
Pfizer Healthcare IrelandStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
This medicinal product is subject to additional monitoring.
*Additional information is available within the SPC or upon request to the company
Updated on 31 January 2024
File name
RegSPCAG32IEclean.pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 4.1 - Therapeutic indications
- Change to section 4.3 - Contraindications
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Section 3 – Updated description of pharmaceutical form.
Section 4.1 – Minor update to indication wording
Section 4.3 – Minor typographical change
Section 5.2 – Updated with information on special populations
Section 6.6 – Updated with information on preparation of infusion solution
Updated on 31 January 2024
File name
RegPIL32UKIEclean.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 11 August 2023
File name
Reg SPC AG 2_1 IE clean.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 11 August 2023
File name
Reg PIL AG 2_1 UK & IE clean.pdf
Reasons for updating
- New PIL for new product