Revised: 31 May 2019
Medicines
Medsafe Product Detail | ||
---|---|---|
File ref: TT50-6157/1 |
Trade Name | Dose Form | Strength | Identifier |
Faslodex | Solution for injection | 250 mg/5mL | |
Sponsor | Application date | Registration situation | Classification |
AstraZeneca Limited P O Box 87453 Meadowbank Auckland 1742 | 15/9/2004 | Consent given Approval date: 16/7/2020 | Prescription |
Composition
Component | Ingredient | Manufacturer |
solution for injection | Active | |
Fulvestrant 50 mg/mL | Ajinomoto 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 step | Manufacturer |
Finished Product Testing | AstraZeneca 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 Form | Vetter 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 | |
Packing | Vetter 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 Packaging | AstraZeneca UK Ltd Silk Road Business Park Macclesfield Cheshire SK10 2NA UNITED KINGDOM |
NZ Site of Product Release | Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics 58 Richard Pearse Drive Airport Oaks Mangere AUCKLAND 2022 |
Packaging
Package | Contents | Shelf Life |
Syringe, glass, , cardboard carton containing two pre-filled 5 mL syringes | 1 dose units | 4 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 Date | Application Type | Change(s) | Status | Payment Date | Priority |
26/2/2024 | Self-Assessable Change Notification | Labelling - G1 (Self assessable) | Notified | 28/2/2024 | |
1/11/2019 | New Higher-risk Medicine Application | New higher-risk medicine containing one or more new active substances | Granted 16/7/2020 | 28/11/2019 | Y |