Revised: 31 May 2019
Medicines
Medsafe Product Detail | ||
|---|---|---|
| File ref: TT50-6378 |
| Trade Name | Dose Form | Strength | Identifier |
| Abelcet | Emulsion for infusion | 5 mg/mL | |
| Sponsor | Application date | Registration situation | Classification |
| Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics P O Box 62027 Sylvia Park AUCKLAND 1644 | 30/4/1999 | Approval lapsed Approval date: 6/5/2010 Notification date: 6/5/2014 | Prescription |
Composition
| Component | Ingredient | Manufacturer |
| emulsion for infusion | Active | |
| Amphotericin B 5 mg/mL (As a lipid complex; For manufacture see DMF TT60-104-24-4) | Xellia Pharmaceuticals ApS Dalslandsgade 11 Copenhagen S DK-2300 DENMARK | |
| Bristol-Myers Squibb Manufacturing Company Unlimited Company State Rd #3, Km 77.5 Humacao 00791 PUERTO RICO | ||
| Excipient | ||
| Dimyristoylphosphatidylcholine | ||
| Dimyristoylphosphatidylglycerol as sodium and ammonium salts | ||
| Sodium chloride | ||
| Water for injection |
Production
| Manufacturing step | Manufacturer |
| Finished Product Testing | Exelead Inc 6925 Guion Road Indianapolis IN 46268-2582 UNITED STATES OF AMERICA |
| Manufacture of Final Dose Form | Exelead Inc 6925 Guion Road Indianapolis IN 46268-2582 UNITED STATES OF AMERICA |
| Packing | Exelead Inc 6925 Guion Road Indianapolis IN 46268-2582 UNITED STATES OF AMERICA |
| 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 |
| Vial, glass, single dose, | 20 mL | 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) |
Indications
ABELCET is indicated for the treatment of invasive fungal disease caused by organisms susceptible to amphotericin B.
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 7/11/2012 | Changed Medicine Notification | Active ingredient manufacturing process - Grade 1 | Granted 19/12/2012 | 13/11/2012 | |
| 19/4/2010 | Provisional Consent (Section 23) | Renewal of provisional consent | Granted 6/5/2010 | 21/4/2010 |
