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 |