Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed medicine which was referred to the Minister of Health under the provisions of section 24 (5) of the Act and is set out in the Schedule hereto:
Schedule
Product: Ciproxin
Active Ingredient: Ciprofloxacin lactate 2.54mg/mL equivalent to ciprofloxacin 2mg/mL
Dosage Form: Solution for infusion
New Zealand Sponsor: Bayer Diagnostics New Zealand Limited
Manufacturer: Bayer Healthcare AG, Bayerwerk, Leverkusen, Germany
Product: Ciproxin
Active Ingredient: Ciprofloxacin 10g
Dosage Form: Microcapsules granules for oral suspension
New Zealand Sponsor: Bayer Diagnostics New Zealand Limited
Manufacturer: Bayer SpA, Garbagnate, Milanese, Italy
Product: Ciproxin
Active Ingredient: Ciprofloxacin 2.5g
Dosage Form: Microcapsules granules for oral suspension
New Zealand Sponsor: Bayer Diagnostics New Zealand Limited
Manufacturer: Bayer SpA, Garbagnate, Milanese, Italy
Product: Ciproxin
Active Ingredient: Ciprofloxacin hydrochloride 116.4mg equivalent to ciprofloxacin 100mg as monohydrate
Dosage Form: Film coated tablet
New Zealand Sponsor: Bayer Diagnostics New Zealand Limited
Manufacturer: Bayer Healthcare AG, Bayerwerk, Leverkusen, Germany
Product: Ciproxin
Active Ingredient: Ciprofloxacin hydrochloride 291mg equivalent to ciprofloxacin 250mg as monohydrate
Dosage Form: Film coated tablet
New Zealand Sponsor: Bayer Diagnostics New Zealand Limited
Manufacturer: Bayer Healthcare AG, Bayerwerk, Leverkusen, Germany
Product: Ciproxin
Active Ingredient: Ciprofloxacin hydrochloride 582mg equivalent to ciprofloxacin 500mg as monohydrate
Dosage Form: Film coated tablet
New Zealand Sponsor: Bayer Diagnostics New Zealand Limited
Manufacturer: Bayer Healthcare AG, Bayerwerk, Leverkusen, Germany
Product: Ciproxin
Active Ingredient: Ciprofloxacin hydrochloride 873mg equivalent to ciprofloxacin 750mg as monohydrate
Dosage Form: Film coated tablet
New Zealand Sponsor: Bayer Diagnostics New Zealand Limited
Manufacturer: Bayer Healthcare AG, Bayerwerk, Leverkusen, Germany
Dated this 1st day of July 2005.
MARK JACOBS, Acting Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on
6 July 2001).