| Active ingredient (INN) | Fentanyl |
|---|---|
| Brand names | Actiq, Abstral, B. Braun, Duragesic, Sublimaze, fentaNYL Citrate +3 more |
| ATC level 5 | N01AH01 |
| ATC level 4 | N01AH |
| Drug class | Strong opioid analgesic/anaesthetic |
| Therapeutic category | Analgesic |
| Strength | 12mcg/h · 25mcg/h · 50mcg/h · 75mcg/h · 100mcg/h · 50mcg/ml injection |
| Dosage form | patch · lozenge · sublingual tablet · solution for injection · nasal spray |
| Route of administration | transdermal · sublingual · intravenous · intranasal · buccal |
| WHO Essential Medicine | Yes · 2.2. Opioid analgesics (2023) |
| Controlled substance | Yes — scheduled |
| Marketing-authorisation holders | Aspen Pharmacare Australia Pty Ltd, Juno Pharmaceuticals Pty Ltd, Medicianz Healthcare Pty Ltd, Takeda Pharmaceuticals Australia Pty Ltd +8 more |
| Registrations on file | 28 |
| Patient information leaflet (PIL) | Not on file |
| Summary of product characteristics (SPC) | Not on file |
| Product | Strength | Form | Market | MA holder | Status |
|---|---|---|---|---|---|
| Marcain 0.125% With Fentanyl | 0.125% | — | 🇦🇺 AU | Aspen Pharmacare Australia Pty Ltd | Active |
| Juno | 100 microgram | — | 🇦🇺 AU | Juno Pharmaceuticals Pty Ltd | Active |
| Juno | 500 microgram | — | 🇦🇺 AU | Juno Pharmaceuticals Pty Ltd | Active |
| Aspen | 100 microgram | — | 🇦🇺 AU | Aspen Pharmacare Australia Pty Ltd | Active |
| Aspen | 250 microgram | — | 🇦🇺 AU | Aspen Pharmacare Australia Pty Ltd | Active |
| Aspen | 500 microgram | — | 🇦🇺 AU | Aspen Pharmacare Australia Pty Ltd | Active |
| Medicianz | 100 microgram | — | 🇦🇺 AU | Medicianz Healthcare Pty Ltd | Active |
| Medicianz | 500 microgram | — | 🇦🇺 AU | Medicianz Healthcare Pty Ltd | Active |
| Medsurge | 100 microgram | — | 🇦🇺 AU | Medicianz Healthcare Pty Ltd | Active |
| Medsurge | 500 microgram | — | 🇦🇺 AU | Medicianz Healthcare Pty Ltd | Active |
| INSTANYL fentanyl | 200 microgram | — | 🇦🇺 AU | Takeda Pharmaceuticals Australia Pty Ltd | Active |
| INSTANYL fentanyl | 50 microgram | — | 🇦🇺 AU | Takeda Pharmaceuticals Australia Pty Ltd | Active |
| FENTANYL 50 MICROGRAMS/ML SOLUTION FOR INJECTION | 50 MICROGRAM | injection | 🇬🇧 GB | MARTINDALE PHARMACEUTICALS LIMITED | Active |
| FENTANYL 50 MICROGRAM/ML INJECTION | 50 MICROGRAM | injection | 🇬🇧 GB | HAMELN PHARMA LTD | Active |
| FENTANYL 50 MICROGRAMS/ML SOLUTION FOR INJECTION/INFUSION | 50 MICROGRAM | injection | 🇬🇧 GB | MERCURY PHARMACEUTICALS LIMITED | Active |