Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1706048
Name of medicinal product: BLINCYTO
Active substances:
Blinatumomab
Estonian, English, Latin
ATC code: L01FX07
Dosage form: powder for concentrate and solution for solution for infusion
Route of administration: intravenous use
Strengh: 38,5mcg
Amount in package: 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information: lahus 10 ml
Indication: BLINCYTO is indicated as monotherapy for the treatment of adults with CD19 positive relapsed or refractory B-precursor acute lymphoblastic leukaemia (ALL). Patients with Philadelphia chromosome positive B-precursor ALL should have failed treatment with at least 2 tyrosine kinase inhibitors (TKIs) and have no alternative treatment options. BLINCYTO is indicated as monotherapy for the treatment of adults with Philadelphia chromosome negative CD19 positive B-precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. BLINCYTO is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with Philadelphia chromosome negative CD19 positive B-precursor ALL which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic haematopoietic stem cell transplantation. BLINCYTO is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with high-risk first relapsed Philadelphia chromosome negative CD19 positive B-precursor ALL as part of the consolidation therapy (see section 4.2).
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: March 22, 2024
: 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: Amgen Europe B.V. 
Marketing authorization number: EU/1/15/1047 
Marketing authorization issued on: November 25, 2015 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: March 17, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

You can download Acrobat Reader fromhere