Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

File ref: TT50-7777/1
Trade NameDose FormStrengthIdentifier
AbacavirOral solution20 mg/mLRex
SponsorApplication dateRegistration situationClassification
REX Medical Ltd
P O Box 18119
Glen Innes
AUCKLAND 1743
27/7/2006Not available
Approval date: 29/7/2010
Notification date: 2/12/2010
Prescription
Reference product: Ziagen Oral solution 20 mg/mL

Composition

ComponentIngredientManufacturer
oral solutionActive 
 Abacavir sulfate 23.4 mg/mL (equivalent to 20 mg/mL abacavir)Mylan Laboratories Limited
Unit 8, Getula Chodavaram
Poosapatirega Mandal
Vizianagaram District
Andhra Pradesh 535 204
India
 Excipient 
 Banana flavour PHS-139122
 Citric acid monohydrate
 Methyl hydroxybenzoate
 Propyl hydroxybenzoate
 Propylene glycol
 Purified water
 Saccharin sodium
 Sodium citrate dihydrate
 Sorbitol
 Strawberry flavour PHS-132963

Production

Manufacturing stepManufacturer
Finished Product TestingCipla Ltd
Unit I, Plot No. L-139, S-103, & M-62
Verna Industrial Estate
Verna, Salcette
Goa 403 722
India
Manufacture of Final Dose FormCipla Ltd
Unit I, Plot No. L-139, S-103, & M-62
Verna Industrial Estate
Verna, Salcette
Goa 403 722
India
PackingCipla Ltd
Unit I, Plot No. L-139, S-103, & M-62
Verna Industrial Estate
Verna, Salcette
Goa 403 722
India
NZ Site of Product ReleaseREX Medical Ltd
67 L Elizabeth Knox Place
Mt. Wellington
Auckland 1006

Packaging

PackageContentsShelf Life
Bottle, White HDPE bottle and white CRC cap (240 ml)240 mL24 months from date of manufacture stored at or below 25°C
2 months opened stored at or below 25°C

Indications

Abacavir oral solution is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults and children.

Latest Regulatory Activity

Application DateApplication TypeChange(s)StatusPayment DatePriority
15/6/2015Changed Medicine NotificationIndications/dosage - Grade 5; Administrative fee (CMN)Granted 2/7/201516/6/2015 
27/7/2006New Intermediate-risk Medicine ApplicationzAdditional dose form - Grade 1Granted 29/7/20103/8/2006 
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