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: Actonel
Active Ingredient: Risedronate sodium 35mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Aventis Pharma Limited
Manufacturer: OSG Norwich Pharmaceutical Inc, Norwich, New York, United States of America
Product: Cancidas
Active Ingredient: Caspofungin acetate 57.8mg equivalent to 50mg caspofungin anhydrous free base
Dosage Form: Powder for concentrate for infusion
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Merck & Co Inc, West Point, Pennsylvania, United States of America
Product: Cancidas
Active Ingredient: Caspofungin acetate 60.6mg equivalent to 50mg caspofungin anhydrous free base
Dosage Form: Powder for infusion
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Merck & Co Inc, West Point, Pennsylvania, United States of America
Product: Cancidas
Active Ingredient: Caspofungin acetate 83.9mg equivalent to 70mg caspofungin anhydrous free base
Dosage Form: Powder for infusion
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Merck & Co Inc, West Point, Pennsylvania, United States of America
Product: Methoxyflurane
Active Ingredient: Methoxyflurane 99.9%w/w
Dosage Form: Volatile liquid for inhalation
New Zealand Sponsor: Airflow Products Limited
Manufacturer: Medical Developments Australia Pty Limited, Springvale, Melbourne, Australia
Product: Primene
Active Ingredients: Alanine 8g/L
Arginine 8.4g/L
Aspartic acid 6g/L
Cysteine 1.89g/L
Glutamic acid 10g/L
Glycine 4g/L
Histidine 3.8g/L
Isoleucine 6.7g/L
Leucine 10g/L
Lysine 11g/L
Methionine 2.4g/L
Ornithine hydrochloride 3.18g/L
Phenylalanine 4.2g/L
Proline 3g/L
Serine 4g/L
Taurine 0.6g/L
Threonine 3.7g/L
Tryptophan 2g/L
Tyrosine 0.45g/L
Valine 7.6g/L
Dosage Form: Solution for infusion
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Clintec Parenteral S.A., Zone Industrielle d'Amilly, Montargis, France
Product: Primene
Active Ingredients: Alanine 4g/L
Arginine 4.2g/L
Aspartic acid 3g/L
Cysteine 0.95g/L
Glutamic acid 5g/L
Glycine 2g/L
Histidine 1.9g/L
Isoleucine 3.35g/L
Leucine 5g/L
Lysine 5.5g/L
Methionine 1.2g/L
Ornithine hydrochloride 1.44g/L
Phenylalanine 2.1g/L
Proline 1.5g/L
Serine 2g/L
Taurine 0.3g/L
Threonine 1.85g/L
Tryptophan 1g/L
Tyrosine 0.45g/L
Valine 3.8g/L
Dosage Form: Solution for infusion
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Clintec Parenteral S.A., Zone Industrielle d'Amilly, Montargis, France
Product: Ritalin LA
Active Ingredient: Methylphenidate hydrochloride 20mg
Dosage Form: Modified release capsule
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Elan Holdings, Gainesville, Georgia, United States of America
Product: Ritalin LA
Active Ingredient: Methylphenidate hydrochloride 30mg
Dosage Form: Modified release capsule
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Elan Holdings, Gainesville, Georgia, United States of America
Product: Ritalin LA
Active Ingredient: Methylphenidate hydrochloride 40mg
Dosage Form: Modified release capsule
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Elan Holdings, Gainesville, Georgia, United States of America
Dated this 28th day of March 2002.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).