Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1749786
Name of medicinal product: BLITZIMA
Active substances:
Rituximab
Estonian, English, Latin
ATC code: L01FA01
Dosage form: concentrate for solution for infusion
Route of administration: intravenous use
Strengh: 500mg 50ml
Amount in package: 50ml 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Blitzima is indicated in adults for the following indications: Non-Hodgkin’s lymphoma (NHL) Blitzima is indicated for the treatment of previously untreated adult patients with stage III-IV follicular lymphoma in combination with chemotherapy. Blitzima maintenance therapy is indicated for the treatment of adult follicular lymphoma patients responding to induction therapy. Blitzima monotherapy is indicated for treatment of adult patients with stage III-IV follicular lymphoma who are chemo-resistant or are in their second or subsequent relapse after chemotherapy. Blitzima is indicated for the treatment of adult patients with CD20 positive diffuse large B cell non-Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy. Blitzima in combination with chemotherapy is indicated for the treatment of paediatric patients (aged ? 6 months to < 18 years old) with previously untreated advanced stage CD20 positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL)/Burkitt leukaemia (mature B-cell acute leukaemia) (BAL) or Burkitt-like lymphoma (BLL). Chronic lymphocytic leukaemia (CLL) Blitzima in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory CLL. Only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including Blitzima or patients refractory to previous Blitzima plus chemotherapy. See section 5.1 for further information. Granulomatosis with polyangiitis and microscopic polyangiitis Blitzima, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (Wegener’s) (GPA) and microscopic polyangiitis (MPA). Blitzima, in combination with glucocorticoids, is indicated for the induction of remission in paediatric patients (aged ? 2 to < 18 years old) with severe, active GPA (Wegener’s) and MPA. Pemphigus vulgaris Blitzima is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (PV).
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: September 25, 2018
Marketing authorization holder: Celltrion Healthcare Hungary Kft. 
Marketing authorization number: EU/1/17/1205 
Marketing authorization issued on: July 17, 2017 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: October 11, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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