| Active ingredient (INN) | Isotretinoin |
|---|---|
| Brand names | Apo, Amnesteem Capsules, USP |
| ATC level 5 | D10AD04 |
| ATC level 4 | D10AD |
| Therapeutic category | Auto-created by Therapeutic Goods Administration — Medicine Shortages scraper |
| Controlled substance | No |
| Marketing-authorisation holders | Southern Cross Pharma Pty Ltd, SUN PHARMACEUTICAL INDUSTRIES EUROPE BV, ENNOGEN HEALTHCARE LTD, Roche Products Pty Ltd |
| Registrations on file | 26 |
| Patient information leaflet (PIL) | Not on file |
| Summary of product characteristics (SPC) | Not on file |
| Product | Strength | Form | Market | MA holder | Status |
|---|---|---|---|---|---|
| ORATANE isotretinoin | 30 mg | — | 🇦🇺 AU | — | Active |
| ISOTRETINOIN LUPIN sotretinoin | 20 mg | — | 🇦🇺 AU | Southern Cross Pharma Pty Ltd | Active |
| Lupin | 10 mg | — | 🇦🇺 AU | Southern Cross Pharma Pty Ltd | Active |
| ORATANE isotretinoin | 5mg | — | 🇦🇺 AU | — | Active |
| Wgr | 20mg | — | 🇦🇺 AU | — | Active |
| Wgr | 10mg | — | 🇦🇺 AU | — | Active |
| ISOTRETINOIN 10 MG SOFT CAPSULES | 10 MG | capsule | 🇬🇧 GB | SUN PHARMACEUTICAL INDUSTRIES EUROPE BV | Active |
| ISOTRETINOIN 20 MG SOFT CAPSULES | 20 MG | capsule | 🇬🇧 GB | SUN PHARMACEUTICAL INDUSTRIES EUROPE BV | Active |
| ISOTRETINOIN 20MG SOFT CAPSULES | 20MG | capsule | 🇬🇧 GB | ENNOGEN HEALTHCARE LTD | Active |
| ISOTRETINOIN 5 MG CAPSULES | 5 MG | capsule | 🇬🇧 GB | ENNOGEN HEALTHCARE LTD | Active |
| ISOTRETINOIN 10 MG CAPSULES, SOFT | 10 MG | capsule | 🇬🇧 GB | ENNOGEN HEALTHCARE LTD | Active |
| ISOTRETINOIN 30 MG SOFT CAPSULES | 30 MG | capsule | 🇬🇧 GB | ENNOGEN HEALTHCARE LTD | Active |
| ROACCUTANE isotretinoin | 20mg | — | 🇦🇺 AU | Roche Products Pty Ltd | Active |
| ORATANE isotretinoin | 20mg | — | 🇦🇺 AU | — | Active |
| ORATANE isotretinoin | 10mg | — | 🇦🇺 AU | — | Active |