Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

CMI
File ref: TT50-5729a
Trade NameDose FormStrengthIdentifier
3TCFilm coated tablet300 mg
SponsorApplication dateRegistration situationClassification
GlaxoSmithKline (NZ) Ltd
Private Bag 106600
Downtown
AUCKLAND 1143
22/9/2000Not available
Approval date: 3/10/2002
Notification date: 20/12/2013
Labelling exemption expires 03/07/2020
Prescription
 

Composition

ComponentIngredientManufacturer
film coated tabletActive 
 Lamivudine 300 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 grey YS-1-17506A
 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
PackingGlaxoSmithKline Pharmaceuticals SA
189 Grunwaldzka Street
Poznan
60-322
Poland
NZ Site of Product ReleaseNo site specified

Packaging

PackageContentsShelf Life
Bottle, plastic, HDPE, 40 mL, child-resistant closure30 tablets36 months from date of manufacture stored at or below 30°C

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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