Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 3062944
Name of medicinal product: ELREXFIO
Active substances:
Elranatamab
Estonian, English, Latin
ATC code: L01FX32
Dosage form: solution for injection
Route of administration: subcutaneous use
Strengh: 40mg 1ml
Amount in package: 1.9ml 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: ELREXFIO is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three 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: Pfizer Europe MA EEIG 
Marketing authorization number: EU/1/23/1770 
Marketing authorization issued on: December 8, 2023 
Marketing authorization expires on: December 8, 2024 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: February 28, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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