Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

File ref: TT50-9873
Trade NameDose FormStrengthIdentifier
Abacavir/Lamivudine MylanFilm coated tablet600 mg/300 mg
SponsorApplication dateRegistration situationClassification
Mylan New Zealand Ltd
P O Box 11183
Ellerslie
AUCKLAND 1542
16/10/2015Not available
Approval date: 17/5/2018
Notification date: 21/5/2018
Prescription
Reference product: Kivexa Film coated tablet 600mg/300mg

Composition

ComponentIngredientManufacturer
film coated tabletActive 
 Abacavir sulfate 702.78 mg equivalent to Abacavir 600 mgMylan Laboratories Limited
Unit 10, Plot 86, Ramky Pharma City (India) Ltd
SEZ, JN Pharma City
Parawada Mandal, Visakhapatnam District
Andhra Pradesh 531019
India
  Mylan Laboratories Limited
Unit 8, Getula Chodavaram
Poosapatirega Mandal
Vizianagaram District
Andhra Pradesh 535 204
India
 Lamivudine 300 mgMylan Laboratories Limited
Unit 2, Survey No. 10 & 42, Gaddapotharam
Kazipally Industrial Area
Sangareddy District
Telangana 502319
India
  Mylan Laboratories Limited
Unit 1, Survey No. 10 / 42
Kazipally Industrial Area, Sangareddy District
Gaddapotharam
Telangana 502319
India
 Excipient 
 Colloidal silicon dioxide
 Crospovidone
 Magnesium stearate
 Microcrystalline cellulose
 Opadry white 13B58894
 Purified talc
 Silicified microcrystalline cellulose

Production

Manufacturing stepManufacturer
Finished Product TestingMylan Laboratories Limited
Plot No H-12 and H-13 MIDC
Waluj, Aurangabad
Maharashtra State 431 136
India
Manufacture of Final Dose FormMylan Laboratories Limited
Plot No H-12 and H-13 MIDC
Waluj, Aurangabad
Maharashtra State 431 136
India
PackingMylan Laboratories Limited
Plot H-12 & H-13 MIDC
Waluj
Aurangabad
Maharashtra State 431 136
India
NZ Site of Product ReleaseMylan New Zealand Ltd
2B George Bourke Drive
Mt. Wellington
Auckland 1060

Packaging

PackageContentsShelf Life
Blister pack, PVC/PVdC/Aluminium30 dose units24 months from date of manufacture stored at or below 25°C
Bottle, HDPE30 dose units24 months from date of manufacture stored at or below 25°C

Indications

Antiretroviral combination therapy for the treatment of HIV in adults and adolescents from 12 years of age.

Latest Regulatory Activity

Application DateApplication TypeChange(s)StatusPayment DatePriority
16/10/2015New Intermediate-risk Medicine ApplicationNew intermediate-risk prescription medicineGranted 17/5/201823/10/2015 
Hide menus
Show menus
0 1 2 4 5 6 7 9 [ /