β¨ Medicine Consent Notices
3 OCTOBER
NEW ZEALAND GAZETTE
Product:
Recormon
Active Ingredient:
Epoetin beta 3,000IU
Dosage Form:
0.3 mL pre-filled syringe Solution for injection
New Zealand Sponsor:
Roche Products (New Zealand) Limited
Manufacturer:
Roche Diagnostics GmbH, Mannheim, Germany
Product:
Recormon
Active Ingredient:
Epoetin beta 4,000IU
Dosage Form:
0.3 mL pre-filled syringe Solution for injection
New Zealand Sponsor:
Roche Products (New Zealand) Limited
Manufacturer:
Roche Diagnostics GmbH, Mannheim, Germany
Product:
Recormon
Active Ingredient:
Epoetin beta 5,000IU
Dosage Form:
0.3 mL pre-filled syringe Solution for injection
New Zealand Sponsor:
Roche Products (New Zealand) Limited
Manufacturer:
Roche Diagnostics GmbH, Mannheim, Germany
Product:
Recormon
Active Ingredient:
Epoetin beta 500IU
Dosage Form:
0.3 mL pre-filled syringe Solution for injection
New Zealand Sponsor:
Roche Products (New Zealand) Limited
Manufacturer:
Roche Diagnostics GmbH, Mannheim, Germany
Product:
Recormon
Active Ingredient:
Epoetin beta 6,000IU
Dosage Form:
0.3 mL pre-filled syringe Solution for injection
New Zealand Sponsor:
Roche Products (New Zealand) Limited
Manufacturer:
Roche Diagnostics GmbH, Mannheim, Germany
Product:
Singulair
Active Ingredient:
Montelukast sodium 4.16mg equivalent to 4mg montelukast free acid
Dosage Form:
Chewable tablet
New Zealand Sponsor:
Merck Sharp & Dohme (New Zealand) Limited
Manufacturers:
Merck & Co Inc, Wilson, North Carolina, United States of America
Merck Sharp & Dohme UK Limited, Cramlington, Northumberland, United Kingdom
Product:
Singulair
Active Ingredient:
Montelukast sodium 5.2mg equivalent to 5mg montelukast free acid
Dosage Form:
Chewable tablet
New Zealand Sponsor:
Merck Sharp & Dohme (New Zealand) Limited
Manufacturers:
Merck Sharp & Dohme UK Limited, Cramlington, Northumberland, United Kingdom
Merck Sharp and Dohme Australia Pty Limited, South Granville, New South Wales, Australia
Product:
Singulair
Active Ingredient:
Montelukast sodium 10.4mg equivalent to 10mg montelukast free acid
Dosage Form:
Film coated tablet
New Zealand Sponsor:
Merck Sharp & Dohme (New Zealand) Limited
Manufacturers:
Merck Sharp & Dohme UK Limited, Cramlington, Northumberland, United Kingdom
Merck Sharp and Dohme Australia Pty Limited, South Granville, New South Wales, Australia
Product:
Zoloft
Active Ingredient:
Sertraline hydrochloride 111.9mg equivalent to 100mg sertraline
Dosage Form:
Film coated tablet
New Zealand Sponsor:
Pfizer Laboratories Limited
Manufacturers:
Pfizer Italiana SpA, Borgo San Michele, Latina, Italy
Pfizer Limited, Sandwich, Kent, England
Pfizer Pharmaceuticals Limited, Dalian, China
Pfizer Pty Limited, West Ryde, New South Wales, Australia
Product:
Zoloft
Active Ingredient:
Sertraline hydrochloride 223.8mg equivalent to 200mg sertraline
Dosage Form:
Film coated tablet
New Zealand Sponsor:
Pfizer Consumer Healthcare Div. of Pfizer Laboratories Limited
Manufacturers:
Pfizer Limited, Sandwich, Kent, England
Pfizer Pty Limited, West Ryde, New South Wales, Australia
3851
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Online Sources for this page:
VUW Te Waharoa —
NZ Gazette 2002, No 147
Gazette.govt.nz —
NZ Gazette 2002, No 147
β¨ LLM interpretation of page content
π₯
Consent to the Distribution of Changed Medicines
(continued from previous page)
π₯ Health & Social WelfareMedicines, Distribution, Recormon, Singulair, Zoloft, Roche Products, Merck Sharp & Dohme, Pfizer Laboratories