Vegzelma 25 mg/mL concentrate 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):
This medicinal product is subject to additional monitoring.
*Additional information is available within the SPC or upon request to the company
Updated on 06 January 2026
File name
SmPC_Vegzelma_en_v13.0_update Jan 2026.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
Addition of “hyaline occlusive glomerular microangiopathy" (frequency not known) to list of adverse reactions. [PRAC recommendation based on PSUR(s) for bevacizumab]
Updated on 19 June 2025
File name
Package Leaflet_Vegzelma_update May 2025.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to improve clarity and readability
Free text change information supplied by the pharmaceutical company
Type IB variation for below editorial changes to Vegzelma package leaflet:
- Addition of texts on polysorbate according to Annex of Excipients Guideline
["This medicine contains 0.4 mg of polysorbate 20 in each mL. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies."]
- Revision of VEGZELMA → Vegzelma
Updated on 19 June 2025
File name
SmPC_Vegzelma_en_v11.0_update May 2025.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to improve clarity and readability
- Updated inline with QRD template and/or excipient guideline
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Type IB variation for below editorial changes to Vegzelma PI
- Addition of texts on polysorbate 20 (excipient with known effect) according to Annex of Excipients Guideline
- Revision of EMA website address
- Correction of manufacturer address
- Revision of VEGZELMA → Vegzelma throughout document
Updated on 22 July 2024
File name
CT-P16_Leaflet(IE_XI)_final_March 2023.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
Added New Doc
Updated on 22 July 2024
File name
SmPC_Vegzelma_en_May 2024.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