Revised: 31 May 2019
Medicines
Medsafe Product Detail |   | |
|---|---|---|
| File ref: TT50-6875b |
| Trade Name | Dose Form | Strength | Identifier |
| Strattera | Capsule | 18 mg | |
| Sponsor | Application date | Registration situation | Classification |
| Eli Lilly and Company (NZ) Limited P O Box 109 197 Newmarket AUCKLAND 1149 | 4/4/2002 | Consent given Approval date: 13/1/2005 | Prescription |
Composition
| Component | Ingredient | Manufacturer |
| capsule | Active | |
| Atomoxetine hydrochloride 20.57mg equivalent to 18 mg atomoxetine free base | Eli Lilly Kinsale Limited Dunderrow Kinsale County Cork P17 NY71 IRELAND | |
| Excipient | ||
| Dimeticone | ||
| Gelatin | ||
| Iron oxide yellow | ||
| Pregelatinised maize starch | ||
| Sodium laurilsulfate | ||
| TekPrint black SW-9008 | ||
| TekPrint black SW-9010 | ||
| Titanium dioxide |
Production
| Manufacturing step | Manufacturer |
| Finished Product Testing | Lilly del Caribe Inc 12.6 km, 65th Infantry Road PR01 Carolina 00985 PUERTO RICO |
| Lilly SA Avda de la Industria, 30 Poligono Industrial Alcobendas Madrid E-28108 SPAIN | |
| Manufacture of Final Dose Form | Lilly del Caribe Inc 12.6 km, 65th Infantry Road PR01 Carolina 00985 PUERTO RICO |
| Packing | Lilly SA Avda de la Industria, 30 Poligono Industrial Alcobendas Madrid E-28108 SPAIN |
| NZ Site of Product Release | DHL Supply Chain (New Zealand) Ltd 6 Manu Tapu Drive Mangere Auckland 2022 |
Packaging
| Package | Contents | Shelf Life |
| Blister pack, Starter pack | 7 capsules | 36 months from date of manufacture stored at or below 25°C |
| Blister pack, PVC/Alcar | 28 capsules | 36 months from date of manufacture stored at or below 25°C |
Indications
STRATTERA is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) as defined by DSM-IV criteria in children 6 years of age and older and adolescents.
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 28/2/2022 | Changed Medicine Notification | Labelling - Grade 2; Administrative fee (CMN) | Granted 12/5/2022 | 4/3/2022 |
