SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|
| BESPONSA 0.9 mg Vial | 0.9 mg | Powder for concentrate for solution for infusion · Intravenous use | 1 Vial | SAR 38487.50 | Biological · Prescription | PFIZER INC | Valid |
Indications — CHI Daman Drug Formulary
ADULT ACUTE LYMPHOCYTIC LEUKEMIA (ALL)
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|
| BESPONSA | 0.9/MG/VIAL | powder, for injection solution, lyophilized powder | WYETH PHARMS INC | Prescription | 17 Aug 2017 |
EMA European Union — centrally authorised medicines
Besponsa Pfizer Europe MA EEIG · Authorised · authorised 28 Jun 2017 · ATC L01FB01
Therapeutic indication (EMA)
Besponsa is indicated as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukaemia (ALL). Adult pPatients with Philadelphia chromosome positive (Ph+) relapsed or refractory B cell precursor ALL should have failed treatment with at least 1 tyrosine kinase inhibitor (TKI). Besponsa is indicated as monotherapy for paediatric patients 1 year and older with CD22-positive B cell precursor ALL: in first relapse after allo-haematopoietic stem cell transplant (HSCT); after any first relapse in patients with Very High Risk (VHR) disease (see section 5.1); after a second or greater relapse; and in those with refractory disease. Patients with Philadelphia chromosome positive (Ph+) disease should have exhausted relevant BCR-ABL targeting treatment options.
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|
| BESPONSA | 02473909 | 0.9 MG / VIAL | POWDER FOR SOLUTION · INTRAVENOUS | PFIZER CANADA ULC |
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.