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: Alustal Alternaria extract
Active Ingredients: Allergen extracts (Alternaria alternata (50%), Alternaria longipes (50%) extracts) 0.1IC/mL
Dosage Form: Vial 1 Solution for injection
Active Ingredients: Allergen extracts (Alternaria alternata (50%), Alternaria longipes (50%) extracts) 1IC/mL
Dosage Form: Vial 2 Solution for injection
Active Ingredients: Allergen extracts (Alternaria alternata (50%), Alternaria longipes (50%) extracts) 10IC/mL
Dosage Form: Vial 3 Solution for injection
New Zealand Sponsor: Ebos Group Limited
Manufacturer: Stallergenes SA, Antony Cedex, France
Product: Alustal Alternaria extract
Active Ingredients: Allergen extracts (Alternaria alternata (50%), Alternaria longipes (50%) extracts) 0.01IC/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Ebos Group Limited
Manufacturer: Stallergenes SA, Antony Cedex, France
Product: Alustal Alternaria extract
Active Ingredients: Allergen extracts (Alternaria alternata (50%), Alternaria longipes (50%) extracts) 10IC/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Ebos Group Limited
Manufacturer: Stallergenes SA, Antony Cedex, France
Product: Alustal American Dust Mite Extract
Active Ingredient: Allergen extract (Dermatophagoides farinae body extract) 0.1IR/mL
Dosage Form: Vial 1 Solution for injection
Active Ingredient: Allergen extract (Dermatophagoides farinae body extract) 1IR/mL
Dosage Form: Vial 2 Solution for injection
Active Ingredient: Allergen extract (Dermatophagoides farinae body extract) 10IR/mL
Dosage Form: Vial 3 Solution for injection
New Zealand Sponsor: Ebos Group Limited
Manufacturer: Stallergenes SA, Antony Cedex, France
Product: Alustal American Dust Mite Extract
Active Ingredient: Allergen extract (Dermatophagoides farinae body extract) 10IR/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Ebos Group Limited
Manufacturer: Stallergenes SA, Antony Cedex, France
Product: Alustal Birch Pollen Extract
Active Ingredient: Allergen extract (Betula alba pollen extract) 0.1IR/mL
Dosage Form: Vial 1 Solution for injection
Active Ingredient: Allergen extract (Betula alba pollen extract) 1IR/mL
Dosage Form: Vial 2 Solution for injection
Active Ingredient: Allergen extract (Betula alba pollen extract) 10IR/mL
Dosage Form: Vial 3 Solution for injection
New Zealand Sponsor: Ebos Group Limited
Manufacturer: Stallergenes SA, Antony Cedex, France
Product: Alustal Birch Pollen Extract
Active Ingredient: Allergen extract (Betula alba pollen extract) 10IR/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Ebos Group Limited
Manufacturer: Stallergenes SA, Antony Cedex, France
Product: Alustal Cat Epithelia Extract
Active Ingredient: Allergen extract (Feline epithelium extract) 0.1IR/mL
Dosage Form: Vial 1 Solution for injection
Active Ingredient: Allergen extract (Feline epithelium extract) 1IR/mL
Dosage Form: Vial 2 Solution for injection
Active Ingredient: Allergen extract (Feline epithelium extract) 10IR/mL
Dosage Form: Vial 3 Solution for injection
New Zealand Sponsor: Ebos Group Limited
Manufacturer: Stallergenes SA, Antony Cedex, France
Product: Alustal Cat Epithelia Extract
Active Ingredient: Allergen extract (Feline epithelium extract) 10IR/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Ebos Group Limited
Manufacturer: Stallergenes SA, Antony Cedex, France
Product: Alustal Compositae Pollen Mix Extract
Active Ingredients: Allergen extracts (A. absinthium (25%), T. vulgarae (25%), X. strumarium (25%), C. leucanthemum (25%) pollen extract) 0.1IC/mL
Dosage Form: Vial 1 Solution for injection
Active Ingredients: Allergen extracts (A. absinthium (25%), T. vulgarae (25%), X. strumarium (25%), C. leucanthemum (25%) pollen extract) 1IC/mL
Dosage Form: Vial 2 Solution for injection
Active Ingredients: Allergen extracts (A. absinthium (25%), T. vulgarae (25%), X. strumarium (25%), C. leucanthemum (25%) pollen extract) 10IC/mL
Dosage Form: Vial 3 Solution for injection
New Zealand Sponsor: Ebos Group Limited
Manufacturer: Stallergenes SA, Antony Cedex, France
Product: Alustal Compositae Pollen Mix Extract
Active Ingredients: Allergen extracts (A. absinthium (25%), T. vulgarae (25%), X. strumarium (25%), C. leucanthemum (25%) pollen extract) 10IC/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Ebos Group Limited
Manufacturer: Stallergenes SA, Antony Cedex, France
Product: Alustal Dog Epithelia Extract
Active Ingredient: Allergen extract (Canine epithelium extract) 0.1IC/mL
Dosage Form: Vial 1 Solution for injection
Active Ingredient: Allergen extract (Canine epithelium extract) 1IC/mL
Dosage Form: Vial 2 Solution for injection
Active Ingredient: Allergen extract (Canine epithelium extract) 10IC/mL
Dosage Form: Vial 3 Solution for injection
New Zealand Sponsor: Ebos Group Limited
Manufacturer: Stallergenes SA, Antony Cedex, France
Product: Alustal Dog Epithelia Extract
Active Ingredient: Allergen extract (Canine epithelium extract) 10IC/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Ebos Group Limited
Manufacturer: Stallergenes SA, Antony Cedex, France
Product: Alustal European Dust Mite Extract
Active Ingredient: Allergen extract (Dermatophagoides pteronyssinus body extract) 0.1IR/mL
Dosage Form: Vial 1 Solution for injection
Active Ingredient: Allergen extract (Dermatophagoides pteronyssinus body extract) 1IR/mL
Dosage Form: Vial 2 Solution for injection
Active Ingredient: Allergen extract (Dermatophagoides pteronyssinus body extract) 10IR/mL
Dosage Form: Vial 3 Solution for injection
New Zealand Sponsor: Ebos Group Limited
Manufacturer: Stallergenes SA, Antony Cedex, France
Product: Alustal European Dust Mite Extract
Active Ingredient: Allergen extract (Dermatophagoides pteronyssinus body extract) 10IR/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Ebos Group Limited
Manufacturer: Stallergenes SA, Antony Cedex, France
Product: Alustal Extract of Five Grasses
Active Ingredients: Allergen extracts (D. glomerate (20%), F. elatior (20%), L. perenne (20%), A. odoratum (20%), P. pratense (20%) extract) 0.1IR/mL
Dosage Form: Vial 1 Solution for injection
Active Ingredients: Allergen extracts (D. glomerate (20%), F. elatior (20%), L. perenne (20%), A. odoratum (20%), P. pratense (20%) extract) 1IR/mL
Dosage Form: Vial 2 Solution for injection
Active Ingredients: Allergen extracts (D. glomerate (20%), F. elatior (20%), L. perenne (20%), A. odoratum (20%), P. pratense (20%) extract) 10IR/mL
Dosage Form: Vial 3 Solution for injection
New Zealand Sponsor: Ebos Group Limited
Manufacturer: Stallergenes SA, Antony Cedex, France
Product: Alustal Extract of Five Grasses
Active Ingredients: Allergen extracts (D. glomerate (20%), F. elatior (20%), L. perenne (20%), A. odoratum (20%), P. pratense (20%) extract) 10IR/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Ebos Group Limited
Manufacturer: Stallergenes SA, Antony Cedex, France
Product: Alustal Fat Hen Pollen Extract
Active Ingredient: Allergen extract (Chenopodium album pollen extract) 0.1IC/mL
Dosage Form: Vial 1 Solution for injection
Active Ingredient: Allergen extract (Chenopodium album pollen extract) 1IC/mL
Dosage Form: Vial 2 Solution for injection
Active Ingredient: Allergen extract (Chenopodium album pollen extract) 10IC/mL
Dosage Form: Vial 3 Solution for injection
New Zealand Sponsor: Ebos Group Limited
Manufacturer: Stallergenes SA, Antony Cedex, France
Product: Alustal Fat Hen Pollen Extract
Active Ingredient: Allergen extract (Chenopodium album pollen extract) 10IC/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Ebos Group Limited
Manufacturer: Stallergenes SA, Antony Cedex, France
Product: Alustal Feathers Mix Extract
Active Ingredients: Allergen extracts (Chicken (33.33%), Duck (33.33%), Goose (33.33%) feathers extract) 0.1IC/mL
Dosage Form: Vial 1 Solution for injection
Active Ingredients: Allergen extracts (Chicken (33.33%), Duck (33.33%), Goose (33.33%) feathers extract) 1IC/mL
Dosage Form: Vial 2 Solution for injection
Active Ingredients: Allergen extracts (Chicken (33.33%), Duck (33.33%), Goose (33.33%) feathers extract) 10IC/mL
Dosage Form: Vial 3 Solution for injection
New Zealand Sponsor: Ebos Group Limited
Manufacturer: Stallergenes SA, Antony Cedex, France
Product: Alustal Feathers Mix Extract
Active Ingredients: Allergen extracts (Chicken (33.33%), Duck (33.33%), Goose (33.33%) feathers extract) 10IC/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Ebos Group Limited
Manufacturer: Stallergenes SA, Antony Cedex, France
Product: Alustal Horse Epithelia Extract
Active Ingredient: Allergen extract (Equine epithelium extract) 0.1IC/mL
Dosage Form: Vial 1 Solution for injection
Active Ingredient: Allergen extract (Equine epithelium extract) 1IC/mL
Dosage Form: Vial 2 Solution for injection
Active Ingredient: Allergen extract (Equine epithelium extract) 10IC/mL
Dosage Form: Vial 3 Solution for injection
New Zealand Sponsor: Ebos Group Limited
Manufacturer: Stallergenes SA, Antony Cedex, France
Product: Alustal Horse Epithelia Extract
Active Ingredient: Allergen extract (Equine epithelium extract) 10IC/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Ebos Group Limited
Manufacturer: Stallergenes SA, Antony Cedex, France
Product: Alustal Oleaceae Pollen Mix extract
Active Ingredients: Allergen extracts (Fraxinus excelsior (33.33%), Olea europaea (33.33%), Ligustrum vulgare (33.33%) pollen extracts) 0.1IC/mL
Dosage Form: Vial 1 Solution for injection
Active Ingredients: Allergen extracts (Fraxinus excelsior (33.33%), Olea europaea (33.33%), Ligustrum vulgare (33.33%) pollen extracts) 1IC/mL
Dosage Form: Vial 2 Solution for injection
Active Ingredients: Allergen extracts (Fraxinus excelsior (33.33%), Olea europaea (33.33%), Ligustrum vulgare (33.33%) pollen extracts) 10IC/mL
Dosage Form: Vial 3 Solution for injection
New Zealand Sponsor: Ebos Group Limited
Manufacturer: Stallergenes SA, Antony Cedex, France
Product: Alustal Oleaceae Pollen Mix Extract
Active Ingredients: Allergen extracts (Fraxinus excelsior (33.33%), Olea europaea (33.33%), Ligustrum vulgare (33.33%) pollen extracts) 10IC/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Ebos Group Limited
Manufacturer: Stallergenes SA, Antony Cedex, France
Product: Alustal Plantain Pollen Extract
Active Ingredient: Allergen extract (Plantago lanceolata pollen extract) 0.1IC/mL
Dosage Form: Vial 1 Solution for injection
Active Ingredient: Allergen extract (Plantago lanceolata pollen extract) 1IC/mL
Dosage Form: Vial 2 Solution for injection
Active Ingredient: Allergen extract (Plantago lanceolata pollen extract) 10IC/mL
Dosage Form: Vial 3 Solution for injection
New Zealand Sponsor: Ebos Group Limited
Manufacturer: Stallergenes SA, Antony Cedex, France
Product: Alustal Plantain Pollen Extract
Active Ingredient: Allergen extract (Plantago lanceolata pollen extract) 10IC/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Ebos Group Limited
Manufacturer: Stallergenes SA, Antony Cedex, France
Product: Alustal Sorrel Pollen Extract
Active Ingredient: Allergen extract (Rumex acetosa pollen extract) 0.1IC/mL
Dosage Form: Vial 1 Solution for injection
Active Ingredient: Allergen extract (Rumex acetosa pollen extract) 1IC/mL
Dosage Form: Vial 2 Solution for injection
Active Ingredient: Allergen extract (Rumex acetosa pollen extract) 10IC/mL
Dosage Form: Vial 3 Solution for injection
New Zealand Sponsor: Ebos Group Limited
Manufacturer: Stallergenes SA, Antony Cedex, France
Product: Alustal Sorrel Pollen Extract
Active Ingredient: Allergen extract (Rumex acetosa pollen extract) 10IC/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Ebos Group Limited
Manufacturer: Stallergenes SA, Antony Cedex, France
Product: Arixtra
Active Ingredient: Fondaparinux sodium 12.5mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: Glaxo Wellcome Production, Notre Dame de Bondeville, France
Product: Arrow – Lisinopril
Active Ingredient: Lisinopril dihydrate 10.89mg equivalent to 10mg lisinopril
Dosage Form: Tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Arrow Laboratories Limited, Croydon, Victoria, Australia
Product: Arrow – Lisinopril
Active Ingredient: Lisinopril dihydrate 21.78mg equivalent to 20mg lisinopril
Dosage Form: Tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Arrow Laboratories Limited, Croydon, Victoria, Australia
Product: Arrow – Lisinopril
Active Ingredient: Lisinopril dihydrate 5.445mg equivalent to 5mg lisinopril
Dosage Form: Tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Arrow Laboratories Limited, Croydon, Victoria, Australia
Product: Arrow – Salbutamol
Active Ingredient: Salbutamol 0.12%w/v – (2.5mg/2.5mL)
Dosage Form: Solution for inhalation
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Laboratoire Unither, Amiens Cedex 2, France
Product: Arrow – Salbutamol
Active Ingredient: Salbutamol 0.24%w/v – (5mg/2.5mL)
Dosage Form: Solution for inhalation
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Laboratoire Unither, Amiens Cedex 2, France
Product: Ciprofloxacin
Active Ingredient: Ciprofloxacin lactate 2.653mg/mL equivalent to Ciprofloxacin 2mg/mL
Dosage Form: Solution for infusion
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Claris Life Sciences Limited, Chacharwadi-Vasana, Ahmedabad, India
Product: Nasaclear
Active Ingredient: Fluticasone propionate 50µg
Dosage Form: Nasal spray suspension
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer: Pacific Pharmaceuticals Limited, Mt Wellington, Auckland
Product: Renagel
Active Ingredient: Sevelamer hydrochloride 400mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited (trading as Healthcare Logistics)
Manufacturer: Genzyme Ireland limited, Waterford, Ireland
Product: Renagel
Active Ingredient: Sevelamer hydrochloride 800mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited (trading as Healthcare Logistics)
Manufacturer: Genzyme Ireland limited, Waterford, Ireland
Product: Vesicare
Active Ingredient: Solifenacin succinate 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: CSL New Zealand Limited
Manufacturer: Astellas Pharma Europe B.V., Meppel, The Netherlands
Product: Vesicare
Active Ingredient: Solifenacin succinate 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: CSL New Zealand Limited
Manufacturer: Astellas Pharma Europe B.V., Meppel, The Netherlands
Product: Voltaren Ophtha
Active Ingredient: Diclofenac sodium 1mg/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: Novartis New Zealand Limited Pharmaceutical Sector
Manufacturer: Excelvision, Annonay Cedex, France
Dated this 13th day of October 2006.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).