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 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: Alustal Extract of Five Grasses (Initial Treatment)
Active Ingredients: Allergen extracts 0.1IR/mL (Vial 1)
Allergen extracts 1IR/mL (Vial 2)
Allergen extracts 10IR/mL (Vial 3)
Dosage Form: Solution for injection
New Zealand Sponsor: Ebos Group Limited
Manufacturer: Stallergenes SA, Antony, France
Product: Alustal Extract of Five Grasses (Maintenance Treatment)
Active Ingredient: Allergen extracts 10IR/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Ebos Group Limited
Manufacturer: Stallergenes SA, Antony, France
Product: Lucentis
Active Ingredient: Ranibizumab 10mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturers: Novartis Pharma Stein AG, Stein, Switzerland
Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany
Sterigenics Belgium SA, Verviers, Belgium
Product: Oralair (Initial Treatment)
Active Ingredients: Grass pollen extract 100IR (Tablet 1)
Allergen extracts 300IR (Tablet 2)
Dosage Form: Sublingual tablet
New Zealand Sponsor: Ebos Group Limited
Manufacturers: Delpharm Lille SAS, Lys Lez Lannoy, France
Cenexi SAS, Osny, France
Product: Oralair (Continuation Treatment)
Active Ingredient: Grass pollen extract 300IR
Dosage Form: Sublingual tablet
New Zealand Sponsor: Ebos Group Limited
Manufacturers: Delpharm Lille SAS, Lys Lez Lannoy, France
Cenexi SAS, Osny, France
Product: Voltaren Emulgel
Active Ingredient: Diclofenac diethylamine 1.16% equivalent to Diclofenac 1%
Dosage Form: Topical gel
New Zealand Sponsor: Novartis Consumer Health Australasia Pty Limited (New Zealand)
Manufacturers: Novartis Consumer Health SA, Nyon, Switzerland
Novartis Pharma Produktions GmbH, Wehr, Germany
Product: Voltaren Emulgel 12 Hourly
Active Ingredient: Diclofenac diethylamine 2.32% equivalent to Diclofenac 2%
Dosage Form: Topical gel
New Zealand Sponsor: Novartis Consumer Health Australasia Pty Limited (New Zealand)
Manufacturer: Novartis Consumer Health SA, Nyon, Switzerland
Product: Voltaren Osteo
Active Ingredient: Diclofenac diethylamine 1.16% equivalent to Diclofenac 1%
Dosage Form: Topical gel
New Zealand Sponsor: Novartis Consumer Health Australasia Pty Limited (New Zealand)
Manufacturers: Novartis Consumer Health SA, Nyon, Switzerland
Novartis Pharma Produktions GmbH, Wehr, Germany
Product: Xarelto
Active Ingredient: Rivaroxaban 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturers: Bayer Healthcare Manufacturing Srl, Milan, Italy
Bayer Pharma AG, Leverkusen, Germany
Product: Xarelto
Active Ingredient: Rivaroxaban 15mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturers: Bayer Healthcare Manufacturing Srl, Milan, Italy
Bayer Pharma AG, Leverkusen, Germany
Product: Xarelto
Active Ingredient: Rivaroxaban 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturers: Bayer Healthcare Manufacturing Srl, Milan, Italy
Bayer Pharma AG, Leverkusen, Germany
Dated this 30th day of May 2014.
SUSAN MARTINDALE, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).