New Zealand Gazette – 1999 – No. 114

Page 2731

✨ Medicines Consent and Renewal

9 SEPTEMBER NEW ZEALAND GAZETTE 2731

Schedule

Product: Amoxyclav.
Active Ingredient(s): Potassium clavulanate 149 mg equivalent to 125 mg clavulanic acid.
Amoxycillin (trihydrate) 294.1 mg equivalent to 250 mg amoxycillin.
Dosage Form: Film coated tablet.
NZ Sponsor: Alpha Pharmaceuticals Limited.
Manufacturer(s): Lek Pharmaceutical and Chemical Company, Ljubljana, Slovenia.

Product: Celebrex.
Active Ingredient(s): Celecoxib 100 mg.
Dosage Form: Capsule.
NZ Sponsor: Searle, Division of Monsanto New Zealand Limited.
Manufacturer(s): Searle & Co, San Juan, Puerto Rico.

Product: Celebrex.
Active Ingredient(s): Celecoxib 200 mg.
Dosage Form: Capsule.
NZ Sponsor: Searle, Division of Monsanto New Zealand Limited.
Manufacturer(s): Searle & Co, San Juan, Puerto Rico.

Product: Gastrolyte-R.
Active Ingredient(s): Potassium chloride 0.3 g.
Sodium citrate (dihydrate) 0.58 g.
Sodium chloride 0.35 g.
Rice powder 0.6 g.
Dosage Form: Powder.
NZ Sponsor: Rhone-Poulenc Rorer New Zealand Limited.
Manufacturer(s): Rhone-Poulenc Rorer Australia Pty Limited, Baulkham Hills, N.S.W., Australia.
Rhone-Poulenc Rorer Australia Pty Limited, West Footscray, Victoria, Australia.

Product: Paxam.
Active Ingredient(s): Clonazepam 0.5 mg.
Dosage Form: Tablet.
NZ Sponsor: Pacific Pharmaceuticals Limited.
Manufacturer(s): Alphapharm Pty Ltd, Brisbane, Queensland, Australia.

Product: Paxam.
Active Ingredient(s): Clonazepam 2 mg.
Dosage Form: Tablet.
NZ Sponsor: Pacific Pharmaceuticals Limited.
Manufacturer(s): Alphapharm Pty Ltd, Brisbane, Queensland, Australia.

Dated this 6th day of September 1999.
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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Renewal of Provisional Consent to the Distribution of a New Medicine

Pursuant to section 23 of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicines set out in the Schedule hereto:

Schedule

Product: Actigall.
Active Ingredient(s): Ursodeoxycholic acid 150 mg.
Dosage Form: Capsule.
NZ Sponsor: Novartis New Zealand Limited.
Manufacturer(s): Novartis Pharma Stein AG/SA, Stein, Switzerland.
Novartis Pharmaceuticals Corporation, New York, U.S.A.

Note: This consent is valid for 2 years from the 7th day of September 1999.

Product: Actigall.
Active Ingredient(s): Ursodeoxycholic acid 300 mg.

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VUW Te Waharoa — NZ Gazette 1999, No 114

NZLII — NZ Gazette 1999, No 114

The General Assembly Library (on the right) was completed in 1899 and survived the 1907 fire. Now the oldest remaining original Parliament building, still used as the Parliamentary Library.

✨ LLM interpretation of page content

🏥 Consent to the Distribution of a New Medicine (continued from previous page)

Domain🏥 Health & Social Welfare
Dated6 September 1999
KeywordsMedicines, Distribution, Consent, Amoxyclav, Celebrex, Gastrolyte-R, Paxam
👩‍💼 Officials

G. R. Boyd, Chief Advisor, Safety and Regulation

🏥 Renewal of Provisional Consent to the Distribution of a New Medicine

Domain🏥 Health & Social Welfare
Dated7 September 1999
KeywordsMedicines, Distribution, Renewal, Actigall

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