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 medicine set out in the Schedule hereto: Schedule Name and Strength Form Name and Address of Manufacturer Proprietary Name(if any) Gemfibrozil 600 mg Tablet, film coated Apotex Inc., Weston, Ontario, Canada Apo-Gemfibrozil Dextromethorphan hydrobromide 1 mg/mL Solution, oral PSM Healthcare Limited, Wiri, Auckland Baxters Tickly Cough Mixture Ascorbic acid 125 mg, biotin 69 g, cholecalciferol 200IU, cocarboxylate tetrahydrate 5.8 mg, cyanocobalamin 6 g, dexpanthenol 16.15 mg, d1-alpha tocopherol 10.2 mg, folic acid 414 g, nicotinamide 46 mg, pyridoxine hydrochloride 5.5 mg, retinol palmitate 3 500IU, riboflavin sodium phosphate 5.67 mg Injection, powder Clintec Nutrition Clinique, Montargis, France; Aquitaine Pharm International, Pierre Fabre Medicament subsidiary, Idron, France; and Laboratoire Lipha, Semoy, France Cernevit Ferrous sulphate (anhydrous) 325 mg providing 105 mg elemental iron, sodium ascorbate 562.4 mg providing 500 mg ascorbic acid Tablet, modified release Abbott Australasia Pty Limited, Kurnell, New South Wales, Australia; and Abbott Laboratories (UK) Limited, Queensborough, Kent, England Ferrograd C Fluorescein sodium 2.5 mg/mL, oxybuprocaine hydrochloride 4 mg/mL Drops, eye solution Akorn Manufacturing Inc., Decatur, Illinois, United States of America Fluress Factor VIII (recombinant) 250IU, 500IU, 1 000IU and water for injection 2.8 mL (as diluent) Injection, powder with diluent Bayer Corporation, Biological Products, Berkeley, California, United States of America Helixate SF Factor VIII (recombinant) 250IU, 500IU, 1 000IU and water for injection 2.8 mL (as diluent) Injection, powder with diluent Bayer Corporation, Biological Products, Berkeley, California, United States of America Kogenate SF Cetylpyridinium chloride 0.05% w/w, sodium fluoride 0.05% w/w Mouthwash, solution SmithKline Beecham Consumer Healthcare, Maidenhead, Berkshire, United Kingdom Macleans Complete Care Coolmint Mouthwash Cetylpyridinium chloride 0.05% w/w, sodium fluoride 0.05% w/w Mouthwash, solution SmithKline Beecham Consumer Healthcare, Maidenhead, Berkshire, United Kingdom Macleans Complete Care Freshmint Mouthwash Follitropin beta 50IU, 75IU, 100IU, 150IU, 200IU, 225IU, 250IU Injection, solution NV Organon, Oss, The Netherlands; and Organon (Ireland) Limited, Swords, County Dublin, Eire Puregon Hydroxyalkyl phosphonate (30% w/w solution) 1 mg/mL, poloxamine 10 mg/mL, polyhexamethylene biguanide 0.0078 mg/mL Solution, contact lens Bausch & Lomb Personal Products Division, Greenville, South Carolina, United States of America ReNu MultiPlus Multi-Purpose Dated this 23rd day of April 1999. G. R. BOYD, Chief Advisor, Regulation and Safety, pursuant to delegation given by the Minister of Health on the 20th day of February 1997.
Publication Date
29 Apr 1999

Notice Number

1999-go3127

Page Number

1185