| Active ingredient (INN) | Topotecan |
|---|---|
| Therapeutic category | Auto-created by FDA Drug Enforcement — Full Recall Database scraper |
| Controlled substance | No |
| Marketing-authorisation holders | Accord Healthcare Pty Ltd, Sandoz Pty Ltd, Fresenius Kabi Australia Pty Ltd, Alphapharm Pty Ltd +12 more |
| Registrations on file | 20 |
| Patient information leaflet (PIL) | Not on file |
| Summary of product characteristics (SPC) | Not on file |
| Product | Strength | Form | Market | MA holder | Status |
|---|---|---|---|---|---|
| Accord | 1 mg | — | 🇦🇺 AU | Accord Healthcare Pty Ltd | Active |
| Intas | 1 mg | — | 🇦🇺 AU | Accord Healthcare Pty Ltd | Active |
| Accord | 4 mg | — | 🇦🇺 AU | Accord Healthcare Pty Ltd | Active |
| Intas | 4 mg | — | 🇦🇺 AU | Accord Healthcare Pty Ltd | Active |
| HYCAMTIN Topotecan | 4mg | — | 🇦🇺 AU | Sandoz Pty Ltd | Active |
| Kabi | 4mg | — | 🇦🇺 AU | Fresenius Kabi Australia Pty Ltd | Active |
| Ag | 4 mg | — | 🇦🇺 AU | Alphapharm Pty Ltd | Active |
| Topotecan | 1mg/mL | injection | 🇺🇸 US | Hospira, Inc. | Active |
| topotecan hydrochloride | 4mg/4mL | injection | 🇺🇸 US | Accord Healthcare, Inc. | Active |
| Topotecan Hospira | — | — | 🌐 EU | Pfizer Europe MA EEIG | Active |
| Topotecan Actavis | — | — | 🌐 EU | ACTAVIS GROUP PTC EHF | Withdrawn |
| Topotecan Teva | — | — | 🌐 EU | Teva B.V. | Withdrawn |
| Topotecan Eagle | — | — | 🌐 EU | Eagle Laboratories Ltd. | Withdrawn |
| Topotecan SUN | — | — | 🌐 EU | Sun Pharmaceutical Industries Europe B.V. | Application withdrawn |
| Topotecan Hydrochloride For | — | solution | 🇨🇦 CA | PFIZER CANADA ULC | Active |