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Notice Type
Departmental
Notice Title

Consent to the Distribution of New Medicines

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines set out in the Schedule hereto:
Schedule
Product: Androderm
Active Ingredient: Testosterone 24.3mg
Dosage Form: Transdermal patch
New Zealand Sponsor: Hospira NZ Limited
Manufacturer: Watson Laboratories Inc, Salt Lake City, Utah, United States of America
Product: Aspen Ceftriaxone
Active Ingredient: Ceftriaxone sodium 1.079g equivalent to 1g ceftriaxone
Dosage Form: Powder for injection
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Quantum Life Sciences Pvt Limited, Bannerghatta Road, Bangalore, India
Product: Aspen Ceftriaxone
Active Ingredient: Ceftriaxone sodium 2.158g equivalent to 2g ceftriaxone
Dosage Form: Powder for infusion
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Quantum Life Sciences Pvt Limited, Bannerghatta Road, Bangalore, India
Product: A-Tramadol
Active Ingredient: Tramadol hydrochloride 50mg
Dosage Form: Capsule
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Athal, Silvassa, Dadra and Nagar Haveli (U T), India
Product: Colgate Total 12 Hour Protection - Advanced Clean
Active Ingredients: Sodium fluoride 0.243%w/w
Triclosan 0.3%w/w
Dosage Form: Toothpaste
New Zealand Sponsor: Colgate-Palmolive Limited (NZ)
Manufacturer: Colgate-Palmolive (Thailand) Limited, Amphur Muang, Chonburi, Thailand
Product: Doxorubicin - Rex
Active Ingredient: Doxorubicin hydrochloride 10mg
Dosage Form: Powder for injection
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Manufacturing Division,Verna, Salcette, Goa, India
Product: Doxorubicin - Rex
Active Ingredient: Doxorubicin hydrochloride 50mg
Dosage Form: Powder for injection
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Manufacturing Division,Verna, Salcette, Goa, India
Product: Frusemide-Claris
Active Ingredient: Furosemide 10mg
Dosage Form: Solution for injection
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Claris Life Sciences Limited, Chacharwadi-Vasana, Ahmedabad, Gujarat, India
Product: Ibuprofen (Pharmacy Only)
Active Ingredient: Ibuprofen 200mg
Dosage Form: Liquid filled capsule
New Zealand Sponsor: Nova Pharmaceuticals NZ Limited
Manufacturer: Marksans Pharma Limited,Verna, Goa, India
Product: Ibuprofen (General Sales)
Active Ingredient: Ibuprofen 200mg
Dosage Form: Liquid filled capsule
New Zealand Sponsor: Nova Pharmaceuticals NZ Limited
Manufacturer: Marksans Pharma Limited,Verna, Goa, India
Product: I-Tramadol
Active Ingredient: Tramadol hydrochloride 50mg
Dosage Form: Capsule
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Athal, Silvassa, Dadra and Nagar Haveli (U T), India
Product: Lorstat 10
Active Ingredient: Atorvastatin calcium 10.36mg equivalent to 10mg atorvastatin
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Pharmaceuticals ULC, Etobicoke, Ontario, Canada
Product: Lorstat 20
Active Ingredient: Atorvastatin calcium 20.72mg equivalent to 20mg atorvastatin
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Pharmaceuticals ULC, Etobicoke, Ontario, Canada
Product: Lorstat 40
Active Ingredient: Atorvastatin calcium 41.44mg equivalent to 40mg atorvastatin
Dosage Form: Tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Pharmaceuticals ULC, Etobicoke, Ontario, Canada
Product: Lorstat 80
Active Ingredient: Atorvastatin calcium 82.88mg equivalent to 80mg atorvastatin
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Pharmaceuticals ULC, Etobicoke, Ontario, Canada
Product: Metchek 500
Active Ingredient: Metformin hydrochloride 500mg
Dosage Form: Film coated tablet
New Zealand Sponsor: PSM Healthcare Limited trading as API Consumer Brands
Manufacturer: Indoco Remedies Limited,Verna, Goa, India
Product: Metchek 850
Active Ingredient: Metformin hydrochloride 850mg
Dosage Form: Film coated tablet
New Zealand Sponsor: PSM Healthcare Limited trading as API Consumer Brands
Manufacturer: Indoco Remedies Limited,Verna, Goa, India
Product: Ondansetron
Active Ingredient: Ondansetron 4mg
Dosage Form: Orodispersible tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Generics, Bachupally, Andhra Pradesh, India
Product: Ondansetron
Active Ingredient: Ondansetron 8mg
Dosage Form: Orodispersible tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Generics, Bachupally, Andhra Pradesh, India
Product: Ondansetron
Active Ingredient: Ondansetron hydrochloride dihydrate 5mg equivalent to ondansetron 4mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Generics, Bachupally, Andhra Pradesh, India
Product: Ondansetron
Active Ingredient: Ondansetron hydrochloride dihydrate 10mg equivalent to ondansetron 8mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Generics, Bachupally, Andhra Pradesh, India
Product: Picosalax
Active Ingredients: Citric acid, anhydrous 12g
Light magnesium oxide 3.5g
Sodium picosulfate 10mg
Dosage Form: Solution, oral powder for
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturers: Pharmaserve Limited, Clifton Technology Park, Swinton, Manchester, United Kingdom
Ferring Pharmaceuticals China (Co) Limited, National Health Technology Park, Sanzhou, Zhongshan City, Guangdong Province, China
Product: ReTrieve Cream
Active Ingredient: Tretinoin 0.5mg/g
Dosage Form: Topical cream
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Baxter Laboratories Pty Limited, Boronia, Victoria, Australia
Product: Tamiflu
Active Ingredient: Oseltamivir phosphate 39.4mg equivalent to oseltamivir 30mg
Dosage Form: Capsule
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: F Hoffmann-La Roche Limited, Basel, Switzerland
Product: Tamiflu
Active Ingredient: Oseltamivir phosphate 59.1mg equivalent to oseltamivir 45mg
Dosage Form: Capsule
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: F Hoffmann-La Roche Limited, Basel, Switzerland
Product: Tramadol hydrochloride
Active Ingredient: Tramadol hydrochloride 50mg
Dosage Form: Capsule
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Athal, Silvassa, Dadra and Nagar Haveli (U T), India
Product: Zapril
Active Ingredient: Cilazapril monohydrate 0.522mg equivalent to Cilazapril anhydrous 0.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Pharmaceuticals ULC, Etobicoke, Ontario, Canada
Dated this 20th day of November 2009.
MARK RICHARDS, Acting Deputy Director-General, Regulation and Governance Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).