Notice Type
Departmental
Consent to the Distribution of a New Medicine 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: 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).
Publication Date
9 Sep 1999

Notice Number

1999-go6616

Page Number

2730