Medicines Act Consents




NEW ZEALAND GAZETTE

No. 17


Medicines Act 1981

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:
Cephazolin Sodium for Injection

Active Ingredient(s):
Cephazolin sodium 1,048mg equivalent to 1g cephazolin

Dosage Form:
Powder for injection

New Zealand Sponsor:
Baxter Healthcare Limited

Manufacturer(s):
Biopharma SrL, Santa Palomba, Rome, Italy
Mitim Srl, Brescia, Italy


Product:
Cephazolin Sodium for Injection

Active Ingredient(s):
Cephazolin sodium 524mg equivalent to 500mg cephazolin

Dosage Form:
Powder for injection

New Zealand Sponsor:
Baxter Healthcare Limited

Manufacturer(s):
Biopharma SrL, Santa Palomba, Rome, Italy
Mitim Srl, Brescia, Italy


Product:
Lemnis Fatty Cream HC

Active Ingredient(s):
Hydrocortisone 10mg/g

Dosage Form:
Topical cream

New Zealand Sponsor:
Pharmaco (NZ) Limited

Manufacturer(s):
Yamanouchi Europe BV, Meppel, The Netherlands


Product:
Losec MUPS

Active Ingredient(s):
Omeprazole magnesium 10.3mg equivalent to 10mg omeprazole

Dosage Form:
Film coated tablet

New Zealand Sponsor:
AstraZeneca Limited

Manufacturer(s):
AstraZeneca AB, Södertälje, Sweden


Product:
Losec MUPS

Active Ingredient(s):
Omeprazole magnesium 20.6mg equivalent to 20mg omeprazole

Dosage Form:
Film coated tablet

New Zealand Sponsor:
AstraZeneca Limited

Manufacturer(s):
AstraZeneca AB, Södertälje, Sweden


Product:
Losec MUPS

Active Ingredient(s):
Omeprazole magnesium 41.3mg equivalent to 40mg omeprazole

Dosage Form:
Film coated tablet

New Zealand Sponsor:
AstraZeneca Limited

Manufacturer(s):
AstraZeneca AB, Södertälje, Sweden


Product:
Naropin

Active Ingredient(s):
Ropivacaine hydrochloride (monohydrate) 5.29mg/mL equiv to 5mg/mL Ropivacaine hydrochloride anhydrous

Dosage Form:
Solution for injection

New Zealand Sponsor:
AstraZeneca Limited

Manufacturer(s):
AstraZeneca AB, Södertälje, Sweden


Dated this 7th day of February 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 PDF NZ Gazette 2001, No 17


Gazette.govt.nz PDF NZ Gazette 2001, No 17





✨ LLM interpretation of page content

🏥 Consent to Distribution of New Medicines under Medicines Act 1981

🏥 Health & Social Welfare
7 February 2001
Medicines, Distribution Consent, Cephazolin Sodium, Lemnis Fatty Cream HC, Losec MUPS, Naropin, Pharmaceutical Products
  • G. R. Boyd, Chief Advisor, Safety and Regulation