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: Clobex Shampoo
Active Ingredient: Clobetasol propionate 0.5mg/g
Dosage Form: Shampoo
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Laboratoires Galderma, ZI – Montdésir, (previously Batiment 1), Alby-Sur-Chéran, France
Product: Nurofen Migraine 400 Double Strength
Active Ingredient: Ibuprofen lysinate 684mg equivalent to 400mg ibuprofen
Dosage Form: Film coated tablet
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Reckitt Benckiser Healthcare International Limited, Nottingham, Nottinghamshire, United Kingdom
Product: Venlafaxine – Rex
Active Ingredient: Venlafaxine hydrochloride 170mg equivalent to 150mg venlafaxine
Dosage Form: Modified release capsule
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Manufacturing Division, Kurkumbh Village, Taluka – Daund, District – Pune, Maharashtra State, India
Product: Venlafaxine – Rex
Active Ingredient: Venlafaxine hydrochloride 42.5mg equivalent to 37.5mg venlafaxine
Dosage Form: Modified release capsule
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Manufacturing Division, District – Pune, Maharashtra State, India
Product: Venlafaxine – Rex
Active Ingredient: Venlafaxine hydrochloride 85mg equivalent to 75mg venlafaxine
Dosage Form: Modified release capsule
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Manufacturing Division, District – Pune, Maharashtra State, India
Dated this 30th day of August 2007.
JOHN HAZELDINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).