Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines set out in the Schedule hereto:
Schedule
Product: Bonviva
Active Ingredient: Ibandronate sodium monohydrate 2.813mg equivalent to ibandronic acid 2.5mg
Dosage Form: Tablet
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: F Hoffmann-La Roche Limited, Basel, Switzerland
Product: Duratocin
Active Ingredient: Carbetocin 100Ág
Dosage Form: Solution for injection
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturer: Ferring AB, Limhamn, Sweden
Product: Hemohes
Active Ingredient: Poly-O-(2-hydroxyethyl)-starch 6%w/v
Dosage Form: Solution for injection
New Zealand Sponsor: Biomed Limited
Manufacturer: Biomed Limited, Pt Chevalier, Auckland
Product: Keppra
Active Ingredient: Levetiracetam 1,000mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Muir Hutchison Limited
Manufacturer: UCB S.A., Chemin du Foriest, Braine-l'Alleud, Brussels, Belgium
Product: Keppra
Active Ingredient: Levetiracetam 250mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Muir Hutchison Limited
Manufacturer: UCB S.A., Chemin du Foriest, Braine-l'Alleud, Brussels, Belgium
Product: Keppra
Active Ingredient: Levetiracetam 500mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Muir Hutchison Limited
Manufacturer: UCB S.A., Chemin du Foriest, Braine-l'Alleud, Brussels, Belgium
Product: Keppra
Active Ingredient: Levetiracetam 750mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Muir Hutchison Limited
Manufacturer: UCB S.A., Chemin du Foriest, Braine-l'Alleud, Brussels, Belgium
Product: Relestat
Active Ingredient: Epinastine hydrochloride 0.5mg/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: Allergan New Zealand Limited
Manufacturer: Allergan Pharmaceuticals Ireland, Westport, County Mayo, Ireland
Product: Reminyl Prolonged Release Capsules (Combination Starter Pack)
Active Ingredient: Galantamine hydrobromide 10.25mg equivalent to 8mg galantamine base
Dosage Form: Capsule
Active Ingredient: Galantamine hydrobromide 20.51mg equivalent to 16 mg galantamine base
Dosage Form: Capsule
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer: Janssen-Cilag SpA, Borgo San Michele, Latina, Italy
Product: Reminyl Prolonged Release Capsules
Active Ingredient: Galantamine hydrobromide 20.51mg equivalent to 16mg galatamine base
Dosage Form: Modified release capsule
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer: Janssen-Cilag SpA, Borgo San Michele, Latina, Italy
Product: Reminyl Prolonged Release Capsules
Active Ingredient: Galantamine hydrobromide 30.76mg equivalent to galantamine base 24mg
Dosage Form: Modified release capsule
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer: Janssen-Cilag SpA, Borgo San Michele, Latina, Italy
Product: Reminyl Prolonged Release Capsules
Active Ingredient: Galantamine hydrobromide 10.25mg equivalent to galantamine base 8mg
Dosage Form: Modified release capsule
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer: Janssen-Cilag SpA, Borgo San Michele, Latina, Italy
Product: Yasmin
Active Ingredients: Drospirenone 3mg
Ethinyloestradiol 30Ág
Dosage Forms: 21 active film coated tablets
7 inactive film coated tablets
New Zealand Sponsor: Schering (NZ) Limited
Manufacturer: Schering GmbH und Co Produktions KG, Weimar, Germany
Product: Zaditen
Active Ingredient: Ketotifen fumarate 345Ág/mL equivalent to ketotifen 250Ág/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Excelvision, La Lombardiere Industrial Zone, Annonay Cedex, France
Dated this 16th day of December 2004.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).