Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

Data SheetCMI
File ref: TT50-6157/1
Trade NameDose FormStrengthIdentifier
FaslodexSolution for injection250 mg/5mL
SponsorApplication dateRegistration situationClassification
AstraZeneca Limited
P O Box 87453
Meadowbank
Auckland 1742
15/9/2004Consent given
Approval date: 16/7/2020
Prescription
 

Composition

ComponentIngredientManufacturer
solution for injectionActive 
 Fulvestrant 50 mg/mLAjinomoto OmniChem SA
Cooppallaan 91
Wetteren
Oost-Vlaanderen B-9230
Belgium
  Minakem High Potent SA
Rue Fonds Jean Paques 8
Mont-Saint-Guibert 1435
Belgium
 Excipient 
 Benzyl alcohol
 Benzyl benzoate
 Castor oil
 Ethanol

Production

Manufacturing stepManufacturer
Finished Product TestingAstraZeneca UK Ltd
Silk Road Business Park
Macclesfield
Cheshire SK10 2NA
United Kingdom
 Vetter Pharma-Fertigung GmbH & Co KG
Eisenbahnstrasse 2-4
Langenargen D-88085
Germany
 Vetter Pharma-Fertigung GmbH & Co KG
Helmut-Vetter-Str. 10
Ravensburg
Baden Wurttemberg 88213
Germany
 Vetter Pharma-Fertigung GmbH & Co KG
Mooswiesen 2
Ravensburg D-88214
Germany
 Vetter Pharma-Fertigung GmbH & Co KG
Schuetzenstrasse 87
Ravensburg D-88212
Germany
Manufacture of Final Dose FormVetter Pharma-Fertigung GmbH & Co KG
Eisenbahnstrasse 2-4
Langenargen D-88085
Germany
 Vetter Pharma-Fertigung GmbH & Co KG
Schuetzenstrasse 87, 99-101
Ravensburg D-88212
Germany
PackingVetter Pharma-Fertigung GmbH & Co KG
Eisenbahnstrasse 2-4
Langenargen D-88085
Germany
 Vetter Pharma-Fertigung GmbH & Co KG
Schuetzenstrasse 87
Ravensburg D-88212
Germany
Secondary PackagingAstraZeneca 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
Syringe, glass, , cardboard carton containing two pre-filled 5 mL syringes1 dose units4 years from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Indications

FASLODEX is indicated for the treatment of locally advanced or metastatic breast cancer in postmenopausal women of any age:
- not previously treated with endocrine therapy, or
- previously treated with endocrine therapy (antioestrogen or aromatase inhibitor) therapy, irrespective of whether their postmenopausal status occurred naturally or was artificially induced.

Latest Regulatory Activity

Application DateApplication TypeChange(s)StatusPayment DatePriority
29/7/2020Self-Assessable Change NotificationLabelling - Grade 1 (Self assessable)Notified3/8/2020 
1/11/2019New Higher-risk Medicine ApplicationNew higher-risk medicine containing one or more new active substancesGranted 16/7/202028/11/2019Y
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