✨ Medicines Consent Notices
2 AUGUST
NEW ZEALAND GAZETTE
1951
Product:
Diovan
Active Ingredient(s):
Valsartan 40mg
Dosage Form:
Film coated tablet
New Zealand Sponsor:
Novartis New Zealand Limited
Manufacturer(s):
Novartis Pharma Stein AG/SA, Stein, Switzerland
Product:
Diovan
Active Ingredient(s):
Valsartan 80mg
Dosage Form:
Film coated tablet
New Zealand Sponsor:
Novartis New Zealand Limited
Manufacturer(s):
Novartis Pharma Stein AG/SA, Stein, Switzerland
Product:
Lora-tabs
Active Ingredient(s):
Loratadine 10mg
Dosage Form:
Film coated tablet
New Zealand Sponsor:
Pacific Pharmaceuticals Limited
Manufacturer(s):
Laboratorios Vita S.A., Sant Joan Depsi, Barcelona, Spain
Product:
Ospamox Paediatric Drops
Active Ingredient(s):
Amoxycillin (trihydrate) 114.8mg/mL equivalent to 100mg/mL amoxycillin
Dosage Form:
Granules for oral suspension
New Zealand Sponsor:
Novartis New Zealand Limited
Manufacturer(s):
Biochemie GmbH, Kundl, Austria
Product:
Symbicort 100/6 Turbuhaler
Active Ingredient(s):
Budesonide 80µg/dose equivalent to 100µg metered dose
Eformoterol fumarate 4.5µg/dose equivalent to 6µg metered dose
Dosage Form:
Powder for inhalation
New Zealand Sponsor:
AstraZeneca Limited
Manufacturer(s):
AstraZeneca AB, Södertälje, Sweden
Product:
Symbicort 200/6 Turbuhaler
Active Ingredient(s):
Budesonide 160µg/dose equivalent to 200µg metered dose
Eformoterol fumarate 4.5µg/dose equivalent to 6µg metered dose
Dosage Form:
Powder for inhalation
New Zealand Sponsor:
AstraZeneca Limited
Manufacturer(s):
AstraZeneca AB, Södertälje, Sweden
Dated this 25th day of July 2001.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).
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Consent to the Distribution of Changed Medicines
Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed medicines which were referred to the Minister of Health under the provisions of section 24 (5) of the Act and are set out in the Schedule hereto:
Schedule
Product:
Viracept
Active Ingredient(s):
Nelfinavir mesylate 58.5mg/g equivalent 50 mg/g nelfinavir free base
Dosage Form:
Powder for oral suspension
New Zealand Sponsor:
Roche Products (New Zealand) Limited
Manufacturer(s):
F Hoffmann-La Roche AG, Head Office and manufacturing site, Basel, Switzerland
Note: This product has provisional consent that is valid to 12 February 2002.\n
Product:
Viracept
Active Ingredient(s):
Nelfinavir mesylate 292.25mg equivalent 250 mg nelfinavir free base
Dosage Form:
Tablet
New Zealand Sponsor:
Roche Products (New Zealand) Limited
Manufacturer(s):
F Hoffmann-La Roche AG, Head Office and manufacturing site, Basel, Switzerland
Mova Pharmaceutical Corporation, Villa Blanca Industrial Park, Caguas, Puerto Rico
Productos Roche S.A., Polígono Ind. Leganés, Leganés (Madrid), Spain
Note: This product has provisional consent that is valid to 12 February 2002.
Dated this 25th day of July 2001.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).
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Online Sources for this page:
VUW Te Waharoa —
NZ Gazette 2001, No 81
Gazette.govt.nz —
NZ Gazette 2001, No 81
✨ LLM interpretation of page content
🏥
Consent to Distribution of New Medicines
(continued from previous page)
🏥 Health & Social Welfare25 July 2001
Medicines, Consent, Diovan, Lora-tabs, Ospamox Paediatric Drops, Symbicort Turbuhaler
- G. R. Boyd, Chief Advisor, Safety and Regulation
🏥 Consent to the Distribution of Changed Medicines
🏥 Health & Social Welfare25 July 2001
Medicines, Consent, Viracept, Nelfinavir mesylate
- G. R. Boyd, Chief Advisor, Safety and Regulation