Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

File ref: TT50-7777
Trade NameDose FormStrengthIdentifier
AbacavirFilm coated tablet300 mgRex
SponsorApplication dateRegistration situationClassification
REX Medical Ltd
P O Box 18119
Glen Innes
AUCKLAND 1743
27/7/2006Not available
Approval date: 26/8/2010
Notification date: 2/12/2010
Prescription
Reference product: Ziagen Film coated tablet 300 mg

Composition

ComponentIngredientManufacturer
film coated tabletActive 
 Abacavir sulfate 351.39 mg (equivalent to 300 mg abacavir)Mylan Laboratories Limited
Unit 8, Getula Chodavaram
Poosapatirega Mandal
Vizianagaram District
Andhra Pradesh 535 204
India
 Excipient 
 Colloidal silicon dioxide
 Hypromellose
 Magnesium stearate
 Maize starch
 Microcrystalline cellulose
 Opadry yellow 15C52843
 Sodium starch glycolate

Production

Manufacturing stepManufacturer
Finished Product TestingCipla Ltd
Manufacturing Division
Plot No. A-33/1/2
Patalganga Industrial Area
District Raigad, (Maharashtra) 410 220
India
Manufacture of Final Dose FormCipla Ltd
Manufacturing Division
Plot No. A-33/1/2
Patalganga Industrial Area
District Raigad, (Maharashtra) 410 220
India
PackingCipla Ltd
Manufacturing Division
Plot No. A-33/1/2
Patalganga Industrial Area
District Raigad, (Maharashtra) 410 220
India
NZ Site of Product ReleaseREX Medical Ltd
67 L Elizabeth Knox Place
Mt. Wellington
Auckland 1006

Packaging

PackageContentsShelf Life
Bottle, HDPE bottle with 38mm CRC cap and 1g silical gel bag (60 tablets)60 tablets24 months from date of manufacture stored at or below 30°C

Indications

Abacavir tablets are 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 ApplicationNew medicine that does not contain a new active substanceGranted 26/8/20103/8/2006 
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