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: Gemcitabine Actavis 1000
Active Ingredient: Gemcitabine hydrochloride 1140mg
Dosage Form: Powder for injection
New Zealand Sponsor: CSL Biotherapies (NZ) Limited
Manufacturers: SC Sindan-Pharma SrL, Bucharest, Romania
Actavis Italy S.p.A, Milano, Italy
Product: Gemcitabine Actavis 200
Active Ingredient: Gemcitabine hydrochloride 228mg
Dosage Form: Powder for injection
New Zealand Sponsor: CSL Biotherapies (NZ) Limited
Manufacturers: SC Sindan-Pharma SrL, Bucharest, Romania
Actavis Italy S.p.A, Milano, Italy
Product: Normison
Active Ingredient: Temazepam 10mg
Dosage Form: Tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Sigma Pharmaceuticals Australia Pty Limited, Dandenong, Australia
Product: Norvir
Active Ingredient: Ritonavir 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Abbott Laboratories (NZ) Limited
Manufacturer: Abbott GmbH & Co. KG, Ludwigshafen, Germany
Product: Olanzine-D
Active Ingredient: Olanzapine 5mg
Dosage Form: Orodispersible tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Pharmathen SA, Attikis, Greece
Product: Olanzine-D
Active Ingredient: Olanzapine 10mg
Dosage Form: Orodispersible tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Pharmathen SA, Attikis, Greece
Product: Olanzine-D
Active Ingredient: Olanzapine 15mg
Dosage Form: Orodispersible tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Pharmathen SA, Attikis, Greece
Product: Olanzine-D
Active Ingredient: Olanzapine 20mg
Dosage Form: Orodispersible tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Pharmathen SA, Attikis, Greece
Product: Piozone
Active Ingredient: Pioglitazone hydrochloride 16.53mg equivalent to 15mg pioglitazone
Dosage Form: Tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Alphapharm Pty Limited, Brisbane, Australia
Product: Piozone
Active Ingredient: Pioglitazone hydrochloride 33.06mg equivalent to 30mg pioglitazone
Dosage Form: Tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Alphapharm Pty Limited, Brisbane, Australia
Product: Piozone
Active Ingredient: Pioglitazone hydrochloride 49.59mg equivalent to 45mg pioglitazone
Dosage Form: Tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Alphapharm Pty Limited, Brisbane, Australia
Dated this 26th day of August 2010.
JANICE WILSON, Deputy Director-General, Population Health Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).