✨ Medicines Consent Notices
NEW ZEALAND GAZETTE
No. 109
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).
go6054
Consent to the Distribution of Changed Medicines
Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed medicines which were referred to the Minister of Health under the provisions of section 24 (5) of the Act and are set out in the Schedule hereto:
Schedule
Product:
Acular
Active Ingredient(s):
Ketorolac tromethamine 5mg/mL
Dosage Form:
Eye drops, solution
New Zealand Sponsor:
Allergan New Zealand Limited
Manufacturer(s):
Allergan Pharmaceuticals (Ireland) Limited, Westport, County Mayo, Ireland
Product:
Dilatrend
Active Ingredient(s):
Carvedilol 12.5mg
Dosage Form:
Tablet
New Zealand Sponsor:
Roche Products (New Zealand) Limited
Manufacturer(s):
Roche Diagnostics GmbH, Mannheim, Germany
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Online Sources for this page:
VUW Te Waharoa —
NZ Gazette 2001, No 109
Gazette.govt.nz —
NZ Gazette 2001, No 109
✨ LLM interpretation of page content
🏥
Consent to the Distribution of New Medicines
(continued from previous page)
🏥 Health & Social Welfare22 August 2001
Medicines Act 1981, Dilaudid, Dilaudid-HP, Dimetapp, Mifegyne, Mitozantrone Hydrochloride, Redopril, Knoll Australia Pty Limited, Whitehall Consumer Healthcare (NZ) Limited, Istar Limited, Baxter Healthcare Limited, Novartis New Zealand Limited
- G. R. Boyd, Chief Advisor, Safety and Regulation
🏥 Consent to the Distribution of Changed Medicines
🏥 Health & Social WelfareMedicines Act 1981, Acular, Dilatrend, Allergan New Zealand Limited, Roche Products (New Zealand) Limited