SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|
| BICNU | 100 mg | Powder and solvent for solution for infusion · Intravenous use | 1 Vial | SAR 3743.45 | NCE · Prescription | Emcure Pharmaceuticals Ltd. | Valid |
| Carmustine for Injection, USP | 100 mg | Powder and solvent for solution for infusion · Intravenous use | 1 Vial | SAR 3267.00 | NCE · Prescription | Navinta LLC | Valid |
| Stenar | 100 mg | Powder and solvent for solution for infusion · Intravenous use | 1 Vial | SAR 3058.60 | Generic · Prescription | SUDAIR PHARMA COMPANY | Valid |
Indications — CHI Daman Drug Formulary
ALL TYPES OF LYMPHOMA
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|
| BICNU | 100MG/VIAL | injectable · injection | AVET LIFESCIENCES | Prescription | 7 Mar 1977 |
| GLIADEL | 7.7MG | implant · intracranial | AZURITY | Prescription | 23 Sep 1996 |
| CARMUSTINE | 100MG/VIAL | injectable · injection | NAVINTA LLC | Prescription | 11 Sep 2018 |
| CARMUSTINE | 100MG/VIAL | injectable · injection | AMNEAL | Prescription | 16 Oct 2018 |
| CARMUSTINE | 100MG/VIAL | injectable · injection | PENN LIFE | Prescription | 2 Apr 2019 |
| CARMUSTINE | 100MG/VIAL | injectable · injection | DR REDDYS | Prescription | 22 Oct 2020 |
| CARMUSTINE | 100MG/VIAL | injectable · injection | MEITHEAL | Prescription | 2 Aug 2021 |
| CARMUSTINE | 100MG/VIAL | injectable · injection | MSN | Prescription | 11 May 2023 |
| CARMUSTINE | 100MG/VIAL | injectable · injection | ALEMBIC | Prescription | 20 Oct 2023 |
| CARMUSTINE | 100MG/VIAL | injectable · injection | HENGRUI PHARMA | Discontinued | 12 Mar 2021 |
| CARMUSTINE | 50MG/VIAL; 300MG/VIAL | powder · intravenous | ACCORD HLTHCARE | Discontinued | 16 May 2022 |
| CARMUSTINE | 100MG/VIAL | injectable · injection | INGENUS PHARMS LLC | Discontinued | 21 Jun 2022 |
| CARMUSTINE | 100MG/VIAL | injectable · injection | ACCORD HLTHCARE | Discontinued | 27 Dec 2022 |
| CARMUSTINE | 100MG/VIAL | injectable · injection | PHARMOBEDIENT | Discontinued | 3 Mar 2023 |
EMA European Union — centrally authorised medicines
Carmustine medac (previously Carmustine Obvius) medac Gesellschaft für klinische Spezialpräparate mbH · Authorised · authorised 18 Jul 2018 · ATC L01AD01
Therapeutic indication (EMA)
Carmustine is indicated n adults in the following malignant neoplasms as a single agent or in combination with other antineoplastic agents and/or other therapeutic measures (radiotherapy, surgery): Brain tumours (glioblastoma, brain-stem gliomas, medulloblastoma, astrocytoma and ependymoma), brain metastases Secondary therapy in non-Hodgkin’s lymphoma and Hodgkin’s disease as conditioning treatment prior to autologous haematopoietic progenitor cell transplantation (HPCT) in malignant haematological diseases (Hodgkin’s disease / Non-hodgkin’s lymphoma).
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|
| BICNU | 00297763 | 100 MG / VIAL | POWDER FOR SOLUTION · INTRAVENOUS | MARCAN PHARMACEUTICALS INC |
| CARMUSTINE FOR INJECTION USP | 02531879 | 100 MG / VIAL | POWDER FOR SOLUTION · INTRAVENOUS | STERIMAX INC |
Safety signals and safety-related labeling changes
- US FDA 5 Dec 2018 GLIADEL — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 24 Mar 2017 BICNU — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
All safety entries for carmustine →
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.