β¨ Medicines Notices
NEW ZEALAND GAZETTE, No. 188
17 DECEMBER 2009
4513
Product: Nicotrol Icy Mint Gum
Active Ingredient: Nicotine 4.4mg equivalent to 22mg nicotine resinate
Dosage Form: Chewing gum
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: McNeil AB, Helsingborg, Sweden
Product: Replagal
Active Ingredient: Agalsidase alfa 1mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Chesapeake Biological Laboratories Inc (CBL), Baltimore, Maryland, United States of America
Product: Ritalin LA
Active Ingredient: Methylphenidate hydrochloride 10mg
Dosage Form: Capsule
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Elan Holdings, Gainesville, Georgia, United States of America
Product: Setrona
Active Ingredient: Sertraline hydrochloride 111.92mg equivalent to sertraline 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Ranbaxy Laboratories Limited, Dewas, Madhya Pradesh, India
Product: Setrona
Active Ingredient: Sertraline hydrochloride 55.96mg equivalent to sertraline 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Ranbaxy Laboratories Limited, Dewas, Madhya Pradesh, India
Product: Simponi
Active Ingredient: Golimumab 50mg
Dosage Form: Solution for injection
New Zealand Sponsor: Schering-Plough a division of Schering-Plough Animal Health Limited
Manufacturer: Baxter Pharmaceutical Solutions LLC, Bloomington, Indiana, United States of America
Product: Simponi SmartJect Injector
Active Ingredient: Golimumab 50mg
Dosage Form: Solution for injection
New Zealand Sponsor: Schering-Plough a division of Schering-Plough Animal Health Limited
Manufacturer: Baxter Pharmaceutical Solutions LLC, Bloomington, Indiana, United States of America
Product: Sprycel
Active Ingredient: Dasatinib 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturer: Bristol-Myers Squibb Company, Mt Vernon, Indiana, United States of America
Product: Tamsulosin Hydrochloride
Active Ingredient: Tamsulosin hydrochloride 0.4mg
Dosage Form: Capsule
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Ranbaxy Laboratories Limited, Dewas, Madhya Pradesh, India
Product: Transipeg
Active Ingredient: Macrogol 3350 5.9g
Dosage Form: Powder for oral solution
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturer: Laboratoires M. Richard, ZI des Reys de Saulce, Saulce sur Rhone, France
Product: Zidoval
Active Ingredient: Metronidazole 7.5mg/g
Dosage Form: Vaginal gel
New Zealand Sponsor: iNova Pharmaceuticals (New Zealand) Limited
Manufacturer: DPT Laboratories Limited, San Antonio, Texas, United States of America
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β¨ LLM interpretation of page content
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Provisional Consent for Medicines
(continued from previous page)
π₯ Health & Social WelfareMedicines Act, New medicines, Provisional Consent, Nicotrol Icy Mint Gum, Replagal, Ritalin LA, Setrona, Simponi, Sprycel, Tamsulosin Hydrochloride, Transipeg, Zidoval
NZ Gazette 2009, No 188