| Active ingredient (INN) | Busulfan |
|---|---|
| Brand names | Busulfano Teva, Busulfan Accord |
| ATC level 5 | L01AB01 |
| ATC level 4 | L01AB |
| Therapeutic category | Auto-created by U.S. Food and Drug Administration — Drug Shortages scraper |
| Controlled substance | No |
| Marketing-authorisation holders | ASPEN PHARMA TRADING LIMITED, Aspen Pharmacare Australia Pty Ltd, Otsuka Australia Pharmaceutical Pty Ltd, Accord Healthcare Pty Ltd +5 more |
| Registrations on file | 13 |
| Patient information leaflet (PIL) | Not on file |
| Summary of product characteristics (SPC) | Not on file |
| Product | Strength | Form | Market | MA holder | Status |
|---|---|---|---|---|---|
| BUSULFAN 2 MG TABLETS | 2 MG | tablet | 🇬🇧 GB | ASPEN PHARMA TRADING LIMITED | Active |
| MYLERAN busulfan | 2mg | — | 🇦🇺 AU | Aspen Pharmacare Australia Pty Ltd | Active |
| BUSULFEX busulfan | 60mg | — | 🇦🇺 AU | Otsuka Australia Pharmaceutical Pty Ltd | Active |
| Arx | 60mg | — | 🇦🇺 AU | — | Active |
| GenRx | 60mg | — | 🇦🇺 AU | — | Active |
| Apo | 60mg | — | 🇦🇺 AU | — | Active |
| Intas | 60 mg | — | 🇦🇺 AU | Accord Healthcare Pty Ltd | Active |
| Accord | 60 mg | — | 🇦🇺 AU | Accord Healthcare Pty Ltd | Active |
| BUSULFAN | 6mg/mL | injection | 🇺🇸 US | Hospira, Inc. | Active |
| Busulfan Fresenius Kabi | — | — | 🌐 EU | Fresenius Kabi Deutschland GmbH | Active |
| Busulfan For | — | solution | 🇨🇦 CA | STERIMAX INC | Active |
| Pms-Busulfan | — | solution | 🇨🇦 CA | PHARMASCIENCE INC | Active |
| BUSULFAN INJECTION | — | solution | 🇨🇦 CA | APOTEX INC | Active |