Revised: 31 May 2019
Medicines
Medsafe Product Detail |   | |
|---|---|---|
| File ref: TT50-7099 |
| Trade Name | Dose Form | Strength | Identifier |
| Stromectol | Tablet | 3 mg | |
| Sponsor | Application date | Registration situation | Classification |
| Merck Sharp & Dohme (New Zealand) Limited P O Box 99851 Newmarket Auckland 1149 | 2/7/2003 | Consent given Approval date: 18/8/2005 | Prescription |
Composition
| Component | Ingredient | Manufacturer |
| tablet | Active | |
| Ivermectin 3mg | Hovione PharmaScience Limited Estrada Coronel Nicolau de Mesquita Taipa MACAU | |
| Excipient | ||
| Butylated hydroxyanisole | ||
| Citric acid | ||
| Magnesium stearate | ||
| Microcrystalline cellulose | ||
| Starch |
Production
| Manufacturing step | Manufacturer |
| Finished Product Testing | Merck Sharp & Dohme BV Waarderwag 39 Haarlem 2003 PC NETHERLANDS |
| Organon Pharma (UK) Limited Shotton Lane Cramlington Northumberland NE23 3JU UNITED KINGDOM | |
| Manufacture of Final Dose Form | Merck Sharp & Dohme BV Waarderwag 39 Haarlem 2003 PC NETHERLANDS |
| Packing | Merck Sharp & Dohme BV Waarderwag 39 Haarlem 2003 PC NETHERLANDS |
| NZ Site of Product Release | Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics 58 Richard Pearse Drive Airport Oaks Mangere AUCKLAND 2022 |
Packaging
| Package | Contents | Shelf Life |
| Blister pack, Aluminium foil | 4 tablets | 24 months from date of manufacture stored at or below 30°C |
| Blister pack, Aluminium foil | 20 tablets | 24 months from date of manufacture stored at or below 30°C |
Indications
· Treatment of intestinal strongyloidiasis (anguillulosis).
· Treatment of proven suspected microfilaraemia in patients with lymphatic filariasis caused by Wuchereria bancrofti.
· Treatment of human sarcoptic scabies after prior treatment has failed. Treatment is justified when the diagnosis of scabies has been established clinically and/or by parasitological examination. Without formal diagnosis, treatment is not justified in case of pruritus.
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 1/12/2023 | Self-Assessable Change Notification | Excipient specifications/test methods - G1 (Self assessable) | Notified | 5/12/2023 |
