Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

CMI
File ref: TT50-5729
Trade NameDose FormStrengthIdentifier
3TCFilm coated tablet150 mg
SponsorApplication dateRegistration situationClassification
GlaxoSmithKline (NZ) Ltd
Private Bag 106600
Downtown
AUCKLAND 1143
4/8/1995Not available
Approval date: 11/6/1998
Notification date: 1/8/2017
Prescription
 

Composition

ComponentIngredientManufacturer
film coated tabletActive 
 Lamivudine 150 mgMylan 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 
 Magnesium stearate
 Microcrystalline cellulose
 Opadry white YS-1-7706-G
 Sodium starch glycolate

Production

Manufacturing stepManufacturer
Finished Product TestingGlaxo Operations UK Limited t/a Glaxo Welcome Operations
Priory Street
Ware
Hertfordshire SG12 0DJ
United Kingdom
 GlaxoSmithKline Pharmaceuticals SA
189 Grunwaldzka Street
Poznan
60-322
Poland
Manufacture of Final Dose FormGlaxo Operations UK Limited t/a Glaxo Welcome Operations
Priory Street
Ware
Hertfordshire SG12 0DJ
United Kingdom
 GlaxoSmithKline Pharmaceuticals SA
189 Grunwaldzka Street
Poznan
60-322
Poland
PackingGlaxo Operations UK Limited t/a Glaxo Welcome Operations
Priory Street
Ware
Hertfordshire SG12 0DJ
United Kingdom
 GlaxoSmithKline Australia Pty Ltd
1061 Mountain Highway
Boronia
VIC 3155
Australia
 GlaxoSmithKline Pharmaceuticals SA
189 Grunwaldzka Street
Poznan
60-322
Poland
NZ Site of Product ReleaseGlaxoSmithKline (NZ) Ltd
11th Floor Zurich House
21 Queen Street
Auckland 1010

Packaging

PackageContentsShelf Life
Bottle, plastic, HDPE, White60 tablets60 months from date of manufacture stored at or below 30°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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