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
Manufacturers: Bayer Healthcare AG, Bayerwerk, Germany
Fresenius Kabi Norge AS, Halden, Norway
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: Fucidin
Active Ingredient: Sodium fusidate 250mg
Dosage Form: Film coated tablet
New Zealand Sponsor: CSL Biotherapies (NZ) Limited
Manufacturer: Laboratoires Leo SA, Vernouillet, France
Product: Somatuline Autogel
Active Ingredient: Lanreotide 24.6%w/w
Dosage Form: Solution for injection
New Zealand Sponsor: New Zealand Medical & Scientific Limited
Manufacturers: Beaufour Ipsen Industrie, Dreux, France
Ipsen Pharma Biotech, Signes, France
Dated this 31st day of May 2007.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).