SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|
| Arnaben | 5 mg/ml | Solution for injection · Intravenous use | 1 Vial | SAR 6290.80 | Generic · Prescription | SUDAIR PHARMA COMPANY | Valid |
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|
| ARRANON | 250MG/50ML (5MG/ML) | injectable · intravenous | SANDOZ | Prescription | 28 Oct 2005 |
| NELARABINE | 250MG/50ML (5MG/ML) | injectable · intravenous | ZYDUS PHARMS | Prescription | 17 Nov 2021 |
| NELARABINE | 250MG/50ML (5MG/ML) | injectable · intravenous | DR REDDYS | Prescription | 22 Dec 2022 |
| NELARABINE | 250MG/50ML (5MG/ML) | injectable · intravenous | MEITHEAL | Prescription | 10 Jan 2023 |
| NELARABINE | 250MG/50ML (5MG/ML); 375MG/75ML (5MG/ML) | injectable · intravenous | SHORLA | Prescription | 3 Mar 2023 |
| NELARABINE | 250MG/50ML (5MG/ML) | injectable · intravenous | AMNEAL | Prescription | 4 Apr 2023 |
| NELARABINE | 250MG/50ML (5MG/ML) | injectable · intravenous | NEXUS | Prescription | 2 Jun 2023 |
| NELARABINE | 250MG/50ML (5MG/ML) | injectable · intravenous | GLAND | Prescription | 3 Jan 2024 |
| NELARABINE | 250MG/50ML (5MG/ML) | injectable · intravenous | ALEMBIC | Prescription | 1 Aug 2024 |
| NELARABINE | 250MG/50ML (5MG/ML) | injectable · intravenous | PHARMOBEDIENT | Prescription | 5 Sep 2024 |
| NELARABINE | 250MG/50ML (5MG/ML) | injectable · intravenous | MSN | Prescription | 13 Sep 2024 |
EMA European Union — centrally authorised medicines
Atriance Sandoz Pharmaceuticals d.d. · Authorised · authorised 22 Aug 2007 · ATC L01BB07
Therapeutic indication (EMA)
Nelarabine is indicated for the treatment of patients with T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. Due to the small patient populations in these disease settings, the information to support these indications is based on limited data.
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|
| ATRIANCE | 02299925 | 5 MG / ML | SOLUTION · INTRAVENOUS | SANDOZ CANADA INCORPORATED |
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.