Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1718388
Name of medicinal product: EMPLICITI
Active substances:
Elotuzumab
Estonian, English, Latin
ATC code: L01FX08
Dosage form: powder for concentrate for solution for infusion
Route of administration: intravenous use
Strengh: 400mg
Amount in package: 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Empliciti is indicated in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in adult patients who have received at least one prior therapy (see sections 4.2 and 5.1). Empliciti is indicated in combination with pomalidomide and dexamethasone for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy (see sections 4.2 and 5.1).
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Bristol-Myers Squibb Pharma EEIG 
Marketing authorization number: EU/1/16/1088 
Marketing authorization issued on: May 11, 2016 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: January 6, 2021
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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