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: Avelox IV 400
Active Ingredient: Moxifloxacin hydrochloride 436.8mg equivalent to 400mg moxifloxacin
Dosage Form: Solution for infusion
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturer: Bayer Healthcare AG, Bayerwerk, Germany
Product: Avelox
Active Ingredient: Moxifloxacin hydrochloride 436.8mg equivalent to 400mg moxifloxacin
Dosage Form: Film coated tablet
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturer: Bayer Healthcare AG, Bayerwerk, Germany
Product: Modavigil
Active Ingredient: Modafinil 100mg
Dosage Form: Tablet
New Zealand Sponsor: CSL New Zealand Limited
Manufacturers: Laboratoires Macors, Zone Industrielle de la Plaine des Isles, Auxerre, France
Laboratoires Opodex Industrie, Saint-Denis, Villeneuve la Garenne, (Hauts-de-Seine), France
Dated this 10th day of August 2006.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).