Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1249916
Name of medicinal product: EVOLTRA
Active substances:
Clofarabine
Estonian, English, Latin
ATC code: L01BB06
Dosage form: concentrate for solution for infusion
Route of administration: intravenous use
Strengh: 1mg 1ml
Amount in package: 20ml 10TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients who have relapsed or are refractory after receiving at least two prior regimens and where there is no other treatment option anticipated to result in a durable response. Safety and efficacy have been assessed in studies of patients ? 21 years old at initial diagnosis (see section 5.1).
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: Sanofi B.V. 
Marketing authorization number: EU/1/06/334 
Marketing authorization issued on: May 2, 2006 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: March 20, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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