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: Cellugel Viscoelastic Solution
Active Ingredient(s): Hypromellose 23mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer(s): Alcon Couvreur SA, Puurs, Belgium
Product: Dilaudid
Active Ingredient(s): Hydromorphone hydrochloride 2mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Knoll Australia Pty Limited
Manufacturer(s): Abbott Laboratories Inc, McPherson, Kansas, United States of America
Product: Dilaudid
Active Ingredient(s): Hydromorphone hydrochloride 1mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: Knoll Australia Pty Limited
Manufacturer(s): Knoll Pharmaceutical Company, Whippany, New Jersey, United States of America
Product: Dilaudid
Active Ingredient(s): Hydromorphone hydrochloride 2mg
Dosage Form: Tablet
New Zealand Sponsor: Knoll Australia Pty Limited
Manufacturer(s): Knoll Pharmaceutical Company, Whippany, New Jersey, United States of America
Product: Dilaudid
Active Ingredient(s): Hydromorphone hydrochloride 4mg
Dosage Form: Tablet
New Zealand Sponsor: Knoll Australia Pty Limited
Manufacturer(s): Knoll Pharmaceutical Company, Whippany, New Jersey, United States of America
Product: Dilaudid
Active Ingredient(s): Hydromorphone hydrochloride 8mg
Dosage Form: Tablet
New Zealand Sponsor: Knoll Australia Pty Limited
Manufacturer(s): Knoll Pharmaceutical Company, Whippany, New Jersey, United States of America
Product: Dilaudid-HP
Active Ingredient(s): Hydromorphone hydrochloride 10mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Knoll Australia Pty Limited
Manufacturer(s): Abbott Laboratories Inc, McPherson, Kansas, United States of America
Product: Dimetapp 12 Hour Nasal Spray
Active Ingredient(s): Oxymetazoline hydrochloride 0.5mg/mL
Dosage Form: Nasal spray solution
New Zealand Sponsor: Whitehall Consumer Healthcare (NZ) Limited
Manufacturer(s): Soul Pattinson Manufacturing Pty Limitrd, Kingsgrove, New South Wales, Australia
Product: Mifegyne
Active Ingredient(s): Mifepristone 200mg
Dosage Form: Tablet
New Zealand Sponsor: Istar Limited
Manufacturer(s): Macors Laboratories, la Plaine des Isles, Auxerre, France
Product: Mitozantrone Hydrochloride Injection Concentrate
Active Ingredient(s): Mitoxantrone hydrochloride 2.33mg/mL equivalent to 2mg/mL mitoxantrone
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer(s): David Bull Laboratories Limited, Mulgrave North, Victoria, Australia
Product: Redopril
Active Ingredient(s): Enalapril maleate 10mg
Dosage Form: Tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): KRKA d d Novo mesto, Novo mesto, Slovenia
Product: Redopril
Active Ingredient(s): Enalapril maleate 20mg
Dosage Form: Tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): KRKA d d Novo mesto, Novo mesto, Slovenia
Product: Redopril
Active Ingredient(s): Enalapril maleate 5mg
Dosage Form: Tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): KRKA d d Novo mesto, Novo mesto, Slovenia
Dated this 22nd day of August 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).