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Medsafe Product Detail

Data SheetCMI
File ref: TT50-6875b
Trade NameDose FormStrengthIdentifier
StratteraCapsule18 mg
SponsorApplication dateRegistration situationClassification
Eli Lilly and Company (NZ) Limited
P O Box 109 197
Newmarket
AUCKLAND 1149
4/4/2002Consent given
Approval date: 13/1/2005
Prescription
 

Composition

ComponentIngredientManufacturer
capsuleActive 
 Atomoxetine hydrochloride 20.57 mg (equivalent to 18 mg atomoxetine free base)Eli Lilly SA
Irish Branch
Dunderrow
Kinsale
County Cork
Ireland
 Excipient 
 Dimeticone
 Gelatin
 Iron oxide yellow
 Pregelatinised maize starch
 Sodium laurilsulfate
 TekPrint black SW-9008
 TekPrint black SW-9010
 Titanium dioxide

Production

Manufacturing stepManufacturer
Finished Product TestingLilly del Caribe Inc
12.6 km, 65th Infantry Road PR1
Carolina 00985
Puerto Rico
 Lilly SA
Avda de la Industria, 30
Poligono Industrial
Alcobendas
Madrid E-28108
Spain
Manufacture of Final Dose FormLilly del Caribe Inc
12.6 km, 65th Infantry Road PR1
Carolina 00985
Puerto Rico
PackingLilly SA
Avda de la Industria, 30
Poligono Industrial
Alcobendas
Madrid E-28108
Spain
NZ Site of Product ReleaseEli Lilly and Company (NZ) Limited
Level 1
123 Ormiston Road
Botany South
Auckland 2016

Packaging

PackageContentsShelf Life
Blister pack, Starter pack7 capsules36 months from date of manufacture stored at or below 25°C
Blister pack, PVC/Alcar 28 capsules36 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 DateApplication TypeChange(s)StatusPayment DatePriority
25/11/2016Self-Assessable Change NotificationData sheet - miscellaneous changes (Self assessable)Notified29/11/2016 
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