Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

File ref: TT50-4890/2
Trade NameDose FormStrengthIdentifier
Habitrol MintChewing gum2 mg
SponsorApplication dateRegistration situationClassification
Novartis Consumer Health Australasia Pty Ltd (NZ)
54 Carbine Road
Mt Wellington
AUCKLAND
30/11/1995Approval lapsed
Approval date: 27/3/1997
Notification date: 30/5/2013
General sale
 

Composition

ComponentIngredientManufacturer
chewing gumActive 
 Nicotine 2 mgSiegfried Ltd
Untere Bruhlstrasse 4
Zofingen CH-4800
Switzerland
 Excipient 
 Acesulfame
 Amberlite
 Butylated hydroxytoluene
 Calcium carbonate
 Carnauba wax
 Eucalyptus
 Glycerol
 Gum base Danoja NOF
 Gum base Danoja
 Mentha x piperita
 Menthol
 Purified talc
 Saccharin
 Saccharin sodium
 Sodium bicarbonate
 Sodium carbonate
 Sorbitol
 Water

Production

Manufacturing stepManufacturer
Finished Product TestingSteins Laboratorium A/S
Hjaltesvej 8
Holstebro DK-7500
Denmark
 Steins Laboratorium A/S
Ladelundsvej 85
DK-6650
Brorup
Denmark
Manufacture of Final Dose FormFertin Pharma A/S
Dandyvej 19
Vejle DK-7100
Denmark
PackingNovartis Consumer Health
Units 4 & 10, Wimsey Way
Alfreton Trading Estate
Somercotes
Derbyshire DE55 4PT
United Kingdom
 Pacific Pharmaceuticals Limited (part of Mylan)
5 Monier Place
Mount Wellington
AUCKLAND
 Pacific Pharmaceuticals Limited (part of Mylan)
5 Prescott Street
Mt Wellington
AUCKLAND
 Pacific Pharmaceuticals Limited (part of Mylan)
67-71,72, 74, 76 Leonard Road
Mt Wellington
AUCKLAND 1060
 Probiotec Pharma Pty Ltd
73 - 83 Cherry Lane
Laverton North
VIC 3026
Australia
Secondary PackagingContract Pharmaceutical Services of Australia Pty Ltd
44 - 48 Waterloo Rd (No longer operational 28.4.06
North Ryde
NSW 2113
Australia
 DHL Exel Supply Chain (Australia) Pty Ltd
16 Picrite Close
Greystanes
NSW 2145
Australia
 DHL Supply Chain (New Zealand) Ltd
6 Manu Tapu Drive
Mangere
Auckland 2022
 DHL Supply Chain (New Zealand) Ltd
Cnr George Bolt Memorial Drive & Manu Tapu Drive
Mangere
AUCKLAND
 Packcentre Marketing Services Pty Ltd
1-5 Siddons Way
Hallam
VIC 3803
Australia
 Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
58 Richard Pearse Drive
Airport Oaks
Mangere
AUCKLAND 2022
 Pharmapak Technologies Pty Ltd
7 Inman Road
Dee Why
NSW 2099
Australia
NZ Site of Product ReleaseNo site specified

Packaging

PackageContentsShelf Life
Blister pack, 1212 pieces24 months from date of manufacture stored at or below 25°C
Blister pack, 2424 pieces24 months from date of manufacture stored at or below 25°C
Blister pack, 9696 pieces24 months from date of manufacture stored at or below 25°C

Latest Regulatory Activity

Application DateApplication TypeChange(s)StatusPayment DatePriority
18/8/2006Changed Medicine NotificationFinished product manufacturing site - Grade 1; Active ingredient specifications/test methods - Grade 2; Administrative fee (CMN)Granted 5/9/200621/8/2006 
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