Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

Data SheetCMI
File ref: TT50-5729/1
Trade NameDose FormStrengthIdentifier
3TCOral solution10 mg/mL
SponsorApplication dateRegistration situationClassification
GlaxoSmithKline (NZ) Ltd
Private Bag 106600
Downtown
AUCKLAND 1143
4/8/1995Consent given
Approval date: 11/6/1998
Prescription
 

Composition

ComponentIngredientManufacturer
oral solutionActive 
 Lamivudine 10 mg/mLMylan Laboratories Limited
Unit 2, Survey No. 10 & 42, Gaddapotharam
Kazipally Industrial Area
Sangareddy District
Telangana 502319
India
  Glaxo Wellcome Manufacturing Pte Ltd
1 Pioneer Sector 1
Jurong 628413
Singapore
 Excipient 
 Banana flavour 59.256 AP0551
 Citric acid
 Methyl hydroxybenzoate
 Propyl hydroxybenzoate
 Propylene glycol
 Purified water
 Sodium citrate dihydrate
 Strawberry flavour 057883 AP0551
 Sucrose

Production

Manufacturing stepManufacturer
Manufacture of Final Dose FormGlaxoSmithKline (Canada) Inc
7333 Mississauga Road North
Mississauga
Ontario L5N 6L4
Canada
PackingGlaxoSmithKline (Canada) Inc
7333 Mississauga Road North
Mississauga
Ontario L5N 6L4
Canada
Secondary PackagingGlaxoSmithKline (Canada) Inc
11 Rimini Mews
Mississauga, Ontario L5N 4K1
Canada
NZ Site of Product ReleaseGlaxoSmithKline (NZ) Ltd
11th Floor Zurich House
21 Queen Street
Auckland 1010

Packaging

PackageContentsShelf Life
Bottle, plastic, 240 mL24 months from date of manufacture stored at or below 25°C

Indications

3TC in combination with other anti-retroviral agents is indicated for the treatment of HIV infected adults and children.

Latest Regulatory Activity

Application DateApplication TypeChange(s)StatusPayment DatePriority
30/10/2018CMN 24(5)Indications/dosage - Grade 3; Administrative fee (CMN)Granted 16/5/201914/11/2018 
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