Notice Type
Departmental
Notice Title

Consent to the Distribution of New Medicines

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: Arrow - Pramipexole 0.25
Active Ingredient: Pramipexole hydrochloride 0.25mg equivalent to Pramipexole 0.18mg
Dosage Form: Tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Cobalt Pharmaceuticals Inc., Ontario, Canada
Product: Arrow - Pramipexole 0.5
Active Ingredient: Pramipexole hydrochloride 0.5mg equivalent to Pramipexole 0.35mg
Dosage Form: Tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Cobalt Pharmaceuticals Inc., Ontario, Canada
Product: Arrow - Pramipexole 1
Active Ingredient: Pramipexole hydrochloride 1mg equivalent to Pramipexole 0.7mg
Dosage Form: Tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Cobalt Pharmaceuticals Inc., Ontario, Canada
Product: Arrow - Pramipexole 1.5
Active Ingredient: Pramipexole hydrochloride 1.5mg equivalent to Pramipexole 1.05mg
Dosage Form: Tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Cobalt Pharmaceuticals Inc., Ontario, Canada
Product: Canesten Clotrimazole Thrush Treatment Once Soft Vaginal Pessary
Active Ingredient: Clotrimazole 500mg
Dosage Form: Pessary
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturer: Catalent France Beinheim SA, Beinheim, France
Product: Canesten Clotrimazole Thrush Treatment Once Soft Vaginal Pessary + Cream
(Combination Product)
Active Ingredient: Clotrimazole 500mg
Dosage Form: Pessary
Active Ingredient: Clotrimazole 10mg/g
Dosage Form: Topical cream
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturers: Catalent France Beinheim SA, Beinheim, France (pessary)
Kern Pharma SL, Barcelona, Spain (topical cream)
Product: DBL Dexamethasone Sodium Phosphate
Active Ingredient: Dexamethasone sodium phosphate 4.37mg/mL equivalent to Dexamethasone phosphate 4mg
Dosage Form: Solution for injection
New Zealand Sponsor: Hospira NZ Limited
Manufacturer: Hospira Australia Pty Limited, Melbourne, Australia
Product: Methotrexate Sandoz
Active Ingredient: Methotrexate 20mg/mL
Dosage Form: Injection with diluent
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturer: EBEWE Pharma GmbH Nfg KG, Unterach am Attersee, Austria
Product: Prograf-XL
Active Ingredient: Tacrolimus 0.5mg
Dosage Form: Modified release capsule
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Astellas Ireland Co. Limited, County Kerry, Ireland
Product: Prograf-XL
Active Ingredient: Tacrolimus 1mg
Dosage Form: Modified release capsule
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Astellas Ireland Co. Limited, County Kerry, Ireland
Product: Prograf-XL
Active Ingredient: Tacrolimus 5mg
Dosage Form: Modified release capsule
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Astellas Ireland Co. Limited, County Kerry, Ireland
Dated this 5th day of December 2011.
DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).
Publication Date
8 Dec 2011

Notice Number

2011-go8506

Page Number

5464

Issue Number

189