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 - Betahistine
Active Ingredient: Betahistine dihydrochloride 8mg
Dosage Form: Tablet
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturers: Intas Pharmaceuticals Limited, Plot No. 457-458, Gujarat, India
Intas Pharmaceuticals Limited, Plot No. 5/6/7, Gujarat, India
Product: Arrow - Betahistine
Active Ingredient: Betahistine dihydrochloride 16mg
Dosage Form: Tablet
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturers: Intas Pharmaceuticals Limited, Plot No. 457-458, Gujarat, India
Intas Pharmaceuticals Limited, Plot No. 5/6/7, Gujarat, India
Product: Arrow - Fluoxetine Dispersible
Active Ingredient: Fluoxetine hydrochloride 22.4mg equivalent to Fluoxetine 20mg
Dosage Form: Dispersible tablet
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Arena Pharmaceuticals GmbH, Zofingen, Switzerland
Product: Methadone Molteni
Active Ingredient: Methadone hydrochloride 1mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: Boucher & Muir (New Zealand) Limited t/a BNM Group
Manufacturer: L. Molteni & C. dei F. lli Alitti Societa di Esercizio S.p.A., Firenze, Italy
Product: Methadone Molteni
Active Ingredient: Methadone hydrochloride 5mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: Boucher & Muir (New Zealand) Limited t/a BNM Group
Manufacturer: L. Molteni & C. dei F. lli Alitti Societa di Esercizio S.p.A., Firenze, Italy
Product: Methadone Molteni
Active Ingredient: Methadone hydrochloride 10mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: Boucher & Muir (New Zealand) Limited t/a BNM Group
Manufacturer: L. Molteni & C. dei F. lli Alitti Societa di Esercizio S.p.A., Firenze, Italy
Dated this 9th day of October 2013.
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).