Product class: Authorized package
Medicinal product class: For human use
Package code: 1860140
Name of medicinal product: ABECMA
Active substances:
Idecabtagene vicleucel
Estonian, English, Latin
ATC code: L01XL07
Dosage form: dispersion for infusion
Route of administration: intravenous use
Strengh:  
Amount in package: 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Abecma is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody and have demonstrated disease progression on the last 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: Bristol-Myers Squibb Pharma EEIG 
Marketing authorization number: EU/1/21/1539 
Marketing authorization issued on: 18 August 2021 
Marketing authorization expires on: 22 March 2029 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: 18 June 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription