✨ Medicine Distribution Consents
NEW ZEALAND GAZETTE
No. 1
Product:
Naropin
Active Ingredient(s):
Ropivacaine hydrochloride (monohydrate) 10.6mg/mL equivalent to 10mg/mL Ropivacaine Hydrochloride anhydrous
Dosage Form:
Solution for injection
New Zealand Sponsor:
AstraZeneca Limited
Manufacturer(s):
AstraZeneca AB, Sodertalje, Sweden
AstraZeneca Pty Ltd, North Ryde, New South Wales, Australia
Product:
Naropin
Active Ingredient(s):
Ropivacaine hydrochloride (monohydrate) 2.12mg/mL equivalent to 2mg/mL Ropivacaine Hydrochloride anhydrous
Dosage Form:
Solution for injection
New Zealand Sponsor:
AstraZeneca Limited
Manufacturer(s):
AstraZeneca AB, Sodertalje, Sweden
AstraZeneca Pty Ltd, North Ryde, New South Wales, Australia
NPBI BV, Runde, Emmer-Compascuum, The Netherlands
Product:
Naropin
Active Ingredient(s):
Ropivacaine hydrochloride (monohydrate) 7.93mg/mL equivalent to 7.5mg/mL Ropivacaine Hydrochloride anhydrous
Dosage Form:
Solution for injection
New Zealand Sponsor:
AstraZeneca Limited
Manufacturer(s):
AstraZeneca AB, Sodertalje, Sweden
AstraZeneca Pty Ltd, North Ryde, New South Wales, Australia
Dated this 5th day of January 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 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:
Atridox
Active Ingredient(s):
Doxycycline hyclate 50mg equivalent to 42.5mg doxycycline
Dosage Form:
Syringe B Powder for injection
New Zealand Sponsor:
The Essential Dental Company Limited
Manufacturer(s):
Atrix Laboratories Inc, Fort Collins, Colorado, United States of America
Product:
Cosudex
Active Ingredient(s):
Bicalutamide 50mg
Dosage Form:
Film coated tablet
New Zealand Sponsor:
AstraZeneca Limited
Manufacturer(s):
AstraZeneca GmbH, Plankstadt, Germany
Product:
Curam
Active Ingredient(s):
Potassium clavulanate 8.6mg/mL equiv to 6.25mg clavulanic acid per ml
Amoxycillin (trihydrate) 28.7mg/mL equivalent to 25mg amoxycillin per ml
Dosage Form:
Powder for oral suspension
New Zealand Sponsor:
Novartis New Zealand Limited
Manufacturer(s):
Biochemie GmbH, Kundl, Austria
Product:
Curam
Active Ingredient(s):
Potassium clavulanate 17.2mg/mL equiv to 12.5mg clavulanic acid per ml
Amoxycillin (trihydrate) 57.4mg/mL equiv to 50mg amoxycillin per ml
Dosage Form:
Powder for oral suspension
New Zealand Sponsor:
Novartis New Zealand Limited
Manufacturer(s):
Biochemie GmbH, Kundl, Austria
Product:
Curam
Active Ingredient(s):
Amoxycillin (trihydrate) 287mg equivalent to 250mg Amoxycillin
Potassium clavulanate 153mg equivalent to 125mg clavulanic acid
Dosage Form:
Film coated tablet
New Zealand Sponsor:
Biochemie, a division of Novartis New Zealand Limited
Manufacturer(s):
Biochemie GmbH, Kundl, Austria
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Online Sources for this page:
VUW Te Waharoa —
NZ Gazette 2001, No 1
Gazette.govt.nz —
NZ Gazette 2001, No 1
✨ LLM interpretation of page content
🏥 Consent to Distribution of Naropin Products
🏥 Health & Social Welfare5 January 2001
Medicine, Distribution Consent, Naropin, Ropivacaine Hydrochloride
- G. R. Boyd, Chief Advisor, Safety and Regulation
🏥 Consent to Distribution of New Medicines
🏥 Health & Social Welfare5 January 2001
Medicine, Distribution Consent, Atridox, Cosudex, Curam
- G. R. Boyd, Chief Advisor, Safety and Regulation