SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|
| BLINCYTO | 35 µg | Powder for concentrate for solution for infusion · Intravenous use | 1 Vial | SAR 9946.20 | Biological · Prescription | Amgen Inc. | Valid |
Indications — CHI Daman Drug Formulary
ADULT ACUTE LYMPHOCYTIC LEUKEMIA (ALL); PEDIATRIC ACUTE LYMPHOBLASTIC LEUKAEMIA (ALL)
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|
| BLINCYTO | 35MCG | injectable · injection | AMGEN | Prescription | 3 Dec 2014 |
EMA European Union — centrally authorised medicines
Blincyto Amgen Europe B.V. · Authorised · authorised 23 Nov 2015 · ATC L01FX07
Therapeutic indication (EMA)
Blincyto is indicated as monotherapy for the treatment of adults with CD19 positive relapsed or refractory B‑cell precursor acute lymphoblastic leukaemia (ALL). Patients with Philadelphia chromosome-positive B-cell 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-cell 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 month or older with Philadelphia chromosome-negative CD19 positive B‑cell 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 month or older with high-risk first relapsed Philadelphia chromosome-negative CD19 positive B-cell precursor ALL as part of the consolidation therapy (see section 4.2). Blincyto is indicated as monotherapy as part of consolidation therapy for the treatment of adult patients with newly diagnosed Philadelphia chromosome negative CD19 positive B-cell precursor ALL.
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|
| BLINCYTO | 02450283 | 38.5 MCG / VIAL | POWDER FOR SOLUTION · INTRAVENOUS | AMGEN CANADA INC |
WHO WHO Model List of Essential Medicines (2025)
- 8.2.3. Immunomodulators · complementary
B lymphoblastic leukaemia or lymphoma, not elsewhere classified
Parenteral > General injections > IV: 35 µg in vial; 38.5 µg in vial
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.