Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

File ref: TT50-6378
Trade NameDose FormStrengthIdentifier
AbelcetEmulsion for infusion5 mg/mL
SponsorApplication dateRegistration situationClassification
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
P O Box 62027
Sylvia Park
AUCKLAND 1644
30/4/1999Approval lapsed
Approval date: 6/5/2010
Notification date: 6/5/2014
Prescription
 

Composition

ComponentIngredientManufacturer
emulsion for infusionActive 
 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
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 stepManufacturer
Finished Product TestingExelead Inc
6925 Guion Road
Indianapolis IN 46268-2582
United States of America
Manufacture of Final Dose FormExelead Inc
6925 Guion Road
Indianapolis IN 46268-2582
United States of America
PackingExelead Inc
6925 Guion Road
Indianapolis IN 46268-2582
United States of America
NZ Site of Product ReleasePharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
58 Richard Pearse Drive
Airport Oaks
Mangere
AUCKLAND 2022

Packaging

PackageContentsShelf Life
Vial, glass, single dose, 20 mL24 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 DateApplication TypeChange(s)StatusPayment DatePriority
7/11/2012Changed Medicine NotificationActive ingredient manufacturing process - Grade 1Granted 19/12/201213/11/2012 
19/4/2010Provisional Consent (Section 23)Renewal of provisional consentGranted 6/5/201021/4/2010 
Hide menus
Show menus
0 1 2 4 5 6 7 9 [ /