Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

Data SheetCMI
File ref: TT50-10052a
Trade NameDose FormStrengthIdentifier
TagrissoFilm coated tablet80 mg
SponsorApplication dateRegistration situationClassification
AstraZeneca Limited
P O Box 87453
Meadowbank
Auckland 1742
10/10/2016Consent given
Approval date: 5/10/2017
Prescription
 

Composition

ComponentIngredientManufacturer
film coated tabletActive 
 Osimertinib mesilate 95.4 mg equivalent to osimertinib 80 mgLonza AG
Lonzastrasse
Walliser Werke
Visp CH-3930
Switzerland
 Excipient 
 Hyprolose
 Iron oxide black
 Iron oxide red
 Iron oxide yellow
 Macrogol 3350
 Mannitol
 Microcrystalline cellulose
 Polyvinyl alcohol
 Purified talc
 Sodium stearyl fumarate
 Titanium dioxide

Production

Manufacturing stepManufacturer
Finished Product TestingAstraZeneca AB
Gartunavagen
Sodertalje SE-151 85
Sweden
Manufacture of Final Dose FormAstraZeneca AB
Gartunavagen
Sodertalje SE-151 85
Sweden
PackingAstraZeneca AB
Gartunavagen
Sodertalje SE-151 85
Sweden
NZ Site of Product ReleasePharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
58 Richard Pearse Drive
Airport Oaks
Mangere
AUCKLAND 2022

Packaging

PackageContentsShelf Life
Blister pack, PVC/Al/PA laminate/Al foil blister30 tablets36 months from date of manufacture stored at or below 30°C

Indications

Tagrisso is indicated for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) mutations.

Tagrisso is indicated for the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive non-small cell lung cancer.

Latest Regulatory Activity

Application DateApplication TypeChange(s)StatusPayment DatePriority
19/6/2020Self-Assessable Change NotificationData sheet - miscellaneous changes (Self assessable)Notified30/6/2020 
10/10/2016New Higher-risk Medicine ApplicationAbridged new higher-risk medicine containing one or more new active substanceGranted 5/10/201719/10/2016 
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