Herzuma 150 mg & 420 mg powder for solution for infusion
*Company:
Celltrion Healthcare Ireland Ltd.Status:
UpdatedLegal 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
Updated on 14 April 2025
File name
Package Leaflet_Herzuma 420 mg_update April 2025.pdf
Reasons for updating
- Change to section 2 - excipient warnings
Free text change information supplied by the pharmaceutical company
Addition of polysorbate safety information:
- This medicine contains 1.7 mg of polysorbate 20 in each 420mg vial. Polysorbate may cause allergic reactions. Tell your doctor if you have any known allergies.
Updated on 14 April 2025
File name
Package Leaflet_Herzuma 150 mg_update April 2025.pdf
Reasons for updating
- Change to section 2 - excipient warnings
Free text change information supplied by the pharmaceutical company
Addition of polysorbate safety information:
- This medicine contains 0.6 mg of polysorbate 20 in each 150 mg vial. Polysorbate may cause allergic reactions. Tell your doctor if you have any known allergies.
Updated on 14 April 2025
File name
SmPC_Herzuma 150mg & 420mg_en_update April 2025.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - Marketing authorisation number(s)
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Addition of polysorbate safety information (contains polysorbate 20; polysorbate may cause allergic reactions); addition of 2-pack presentation.
Updated on 22 July 2024
File name
CT-P6 Herzuma_420mg_Leaflet(IE_XI)_final_Jan 2023.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
Current PIL for medicines.ie
Updated on 22 July 2024
File name
CT-P6 Herzuma_150mg_Leaflet(IE_XI)_final_Jan 2023.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
Current PIL for medicines.ie
Updated on 22 July 2024
File name
SmPC_Herzuma_en_Dec 2023.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
New SPC for medicines.ie
Celltrion Healthcare Ireland Ltd.
Address:
26 Arrow Building, Old Belgard Road, Tallaght, Dublin, D24 ND70Medical Information E-mail:
Medinfoie@celltrionhc.comTelephone:
01 223 4026