✨ Medicine Approvals




4 OCTOBER

NEW ZEALAND GAZETTE

3463

Manufacturer(s):

Roche Products Limited, T/A Roche Consumer Health, Welwyn Garden City, Hertfordshire, United Kingdom

Product:
Exelon

Active Ingredient(s):
Rivastigmine hydrogen tartrate 0.8mg equivalent to 0.5mg rivastigmine

Dosage Form:
Capsule

New Zealand Sponsor:
Novartis New Zealand Limited

Manufacturer(s):
Novartis Pharma AG., Basel, Switzerland


Product:
Exelon

Active Ingredient(s):
Rivastigmine hydrogen tartrate 1.6mg equivalent to 1mg rivastigmine

Dosage Form:
Capsule

New Zealand Sponsor:
Novartis New Zealand Limited

Manufacturer(s):
Novartis Pharma Stein AG/SA, Stein, Switzerland


Product:
Exelon

Active Ingredient(s):
Rivastigmine hydrogen tartrate 2.4mg equivalent to 1.5mg rivastigmine

Dosage Form:
Capsule

New Zealand Sponsor:
Novartis New Zealand Limited

Manufacturer(s):
Novartis Farmaceutica SA, Barbera del Valles, Barcelona, Spain
Novartis Pharma Stein AG/SA, Stein, Switzerland


Product:
Exelon

Active Ingredient(s):
Rivastigmine hydrogen tartrate 4.8mg equivalent to 3mg rivastigmine

Dosage Form:
Capsule

New Zealand Sponsor:
Novartis New Zealand Limited

Manufacturer(s):
Novartis Farmaceutica SA, Barbera del Valles, Barcelona, Spain
Novartis Pharma Stein AG/SA, Stein, Switzerland


Product:
Exelon

Active Ingredient(s):
Rivastigmine hydrogen tartrate 7.2mg equivalent to 4.5mg rivastigmine

Dosage Form:
Capsule

New Zealand Sponsor:
Novartis New Zealand Limited

Manufacturer(s):
Novartis Farmaceutica SA, Barbera del Valles, Barcelona, Spain
Novartis Pharma Stein AG/SA, Stein, Switzerland


Product:
Exelon

Active Ingredient(s):
Rivastigmine hydrogen tartrate 9.6mg equivalent to 6mg rivastigmine

Dosage Form:
Capsule

New Zealand Sponsor:
Novartis New Zealand Limited

Manufacturer(s):
Novartis Farmaceutica SA, Barbera del Valles, Barcelona, Spain
Novartis Pharma Stein AG/SA, Stein, Switzerland


Product:
Ospexin

Active Ingredient(s):
Cephalexin (monohydrate) 27.602mg/mL equivalent to 25mg/mL cephalexin

Dosage Form:
Granules for oral suspension

New Zealand Sponsor:
Novartis New Zealand Limited

Manufacturer(s):
Biochemie GmbH, Kundl, Austria


Product:
Ospexin

Active Ingredient(s):
Cephalexin (monohydrate) 55.206mg/mL equivalent to 50mg/mL cephalexin

Dosage Form:
Granules for oral suspension

New Zealand Sponsor:
Novartis New Zealand Limited

Manufacturer(s):
Biochemie GmbH, Kundl, Austria


Product:
Razene

Active Ingredient(s):
Cetirizine hydrochloride 10mg

Dosage Form:
Film coated tablet

New Zealand Sponsor:
Pacific Pharmaceuticals Limited

Manufacturer(s):
Gerard Laboratories, Dublin, Ireland


Product:
Seroquel

Active Ingredient(s):
Quetiapine fumarate 172.69mg equivalent to 150mg quetiapine

Dosage Form:
Film coated tablet

New Zealand Sponsor:
AstraZeneca Limited

Manufacturer(s):
AstraZeneca Pharmaceuticals LP, Newark, Delaware, United States of America
AstraZeneca UK Limited, Macclesfield, Cheshire, United Kingdom


Product:
Seroquel

Active Ingredient(s):
Quetiapine fumarate 345.39mg equivalent to 300mg quetiapine



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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2001, No 135


Gazette.govt.nz PDF NZ Gazette 2001, No 135





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of New Medicines (continued from previous page)

πŸ₯ Health & Social Welfare
Medicines Act, New Medicines, Exelon, Roche Products

πŸ₯ Medicine Approval: Exelon Capsules

πŸ₯ Health & Social Welfare
Medicines Act, Exelon, Rivastigmine hydrogen tartrate, Capsule, Novartis

πŸ₯ Medicine Approval: Ospexin Granules

πŸ₯ Health & Social Welfare
Medicines Act, Ospexin, Cephalexin, Granules for oral suspension, Novartis

πŸ₯ Medicine Approval: Razene Tablets

πŸ₯ Health & Social Welfare
Medicines Act, Razene, Cetirizine hydrochloride, Film coated tablet, Pacific Pharmaceuticals

πŸ₯ Medicine Approval: Seroquel Tablets

πŸ₯ Health & Social Welfare
Medicines Act, Seroquel, Quetiapine fumarate, Film coated tablet, AstraZeneca