| Active ingredient (INN) | Misoprostol |
|---|---|
| Therapeutic category | Auto-created by FDA Drug Enforcement — Full Recall Database scraper |
| Controlled substance | No |
| Marketing-authorisation holders |
|---|
| Norgine Pty Ltd, SUN PHARMACEUTICAL INDUSTRIES EUROPE BV, Pfizer Australia Pty Ltd, MS Health Pty Ltd +3 more |
| Registrations on file | 11 |
|---|
| Patient information leaflet (PIL) | Not on file |
|---|
| Summary of product characteristics (SPC) | Not on file |
|---|
| Product | Strength | Form | Market | MA holder | Status |
|---|---|---|---|---|---|
| ANGUSTA misoprostol | 25 microgram | — | 🇦🇺 AU | Norgine Pty Ltd | Active |
| Medabon: Combipack Of Mifepristone | 200 MG | tablet | 🇬🇧 GB | SUN PHARMACEUTICAL INDUSTRIES EUROPE BV | Active |
| CYTOTEC Misoprostol | 200 microgram | — | 🇦🇺 AU | Pfizer Australia Pty Ltd | Active |
| GyMiso misoprostol | 200 microgram | — | 🇦🇺 AU | MS Health Pty Ltd | Active |
| Ms- | 200 MG | — | 🇦🇺 AU | MS Health Pty Ltd | Active |
| Diclofenac Sodium and Misoprostol | 50; 200mg/1; ug/1 | tablet | 🇺🇸 US | ACTAVIS PHARMA, INC. | Active |
| Diclofenac Sodium and Misoprostol | 75; 200mg/1; ug/1 | tablet | 🇺🇸 US | ACTAVIS PHARMA, INC. | Active |
| Misoprostol | 100ug/1 | tablet | 🇺🇸 US | Novel Laboratories, Inc. | Active |
| Misoprostol | 200ug/1 | tablet | 🇺🇸 US | Novel Laboratories, Inc. | Active |
| Diclofenac Sodium/Misoprostol | 50; 200mg/1; ug/1 | tablet | 🇺🇸 US | MICRO LABS LIMITED | Active |
| Diclofenac Sodium/Misoprostol | 75; 200mg/1; ug/1 | tablet | 🇺🇸 US | MICRO LABS LIMITED | Active |