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 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