Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

Data SheetCMI
File ref: TT50-9989
Trade NameDose FormStrengthIdentifier
LynparzaCapsule50 mg
SponsorApplication dateRegistration situationClassification
AstraZeneca Limited
P O Box 87453
Meadowbank
Auckland 1742
8/6/2016Consent given
Approval date: 10/11/2016
Prescription
 

Composition

ComponentIngredientManufacturer
capsuleActive 
 Olaparib 50 mgLonza AG
Lonzastrasse
Walliser Werke
Visp CH-3930
Switzerland
 Excipient 
 Gellan gum
 Hypromellose
 Lauroyl macrogol-32 glycerides
 Iron oxide black
 Potassium acetate
 Shellac
 Titanium dioxide

Production

Manufacturing stepManufacturer
Finished Product TestingAstraZeneca UK Ltd
Silk Road Business Park
Macclesfield
Cheshire SK10 2NA
United Kingdom
 Patheon Pharmaceuticals Inc
2110 East Galbraith Road
Cincinnati
Ohio 45237-1625
United States of America
Manufacture of Final Dose FormPatheon Pharmaceuticals Inc
2110 East Galbraith Road
Cincinnati
Ohio 45237-1625
United States of America
MicronisationJetpharma SA
via Sottobisio 42a
Balerna CH-6828
Switzerland
PackingAstraZeneca UK Ltd
Silk Road Business Park
Macclesfield
Cheshire SK10 2NA
United Kingdom
NZ Site of Product ReleasePharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
58 Richard Pearse Drive
Airport Oaks
Mangere
AUCKLAND 2022

Packaging

PackageContentsShelf Life
Bottle, plastic, HDPE bottle with PP CRC, 4 bottles x 112 capsules448 capsules24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)
3 months opened stored at or below 25°C

Indications

LYNPARZA is indicated as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed BRCA-mutated (germline or somatic) high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete response or partial response) after platinum-based chemotherapy. Prior treatment must have included at least 2 courses of platinum-based regimens.

Latest Regulatory Activity

Application DateApplication TypeChange(s)StatusPayment DatePriority
28/1/2022Self-Assessable Change NotificationData sheet - miscellaneous changes (Self assessable)Notified2/2/2022 
8/6/2016New Higher-risk Medicine ApplicationAbridged new higher-risk medicine containing one or more new active substanceGranted 10/11/201614/6/2016Y
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