Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1898758
Name of medicinal product: COLUMVI
Active substances:
glofitamab
Estonian, English, Latin
ATC code: L01FX28
Dosage form: concentrate for solution for infusion
Route of administration: intravenous use
Strengh: 2,5mg 2.5ml
Amount in package: 2.5ml 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Columvi as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: Never imported to Estonia
: This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Patients and healthcare professionals are asked to report any suspected adverse reactions to State Agency of Medicines.State Agency of Medicines
Marketing authorization holder: Roche Registration GmbH 
Marketing authorization number: EU/1/23/1742 
Marketing authorization issued on: July 7, 2023 
Marketing authorization expires on: July 10, 2024 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: March 5, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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