Medicines Consent Notices




NEW ZEALAND GAZETTE, No. 143
17 OCTOBER 2013


Product:
Nitro-Dur 5
Active Ingredient:
Glyceryl trinitrate 40mg
Dosage Form:
Transdermal patch
New Zealand Sponsor:
Merck Sharp & Dohme (New Zealand) Limited
Manufacturers:
Merck Sharp & Dohme Corp, Florida, United States of America
Schering-Plough SA, Madrid, Spain

Product:
Nitro-Dur 7.5
Active Ingredient:
Glyceryl trinitrate 60mg
Dosage Form:
Transdermal patch
New Zealand Sponsor:
Merck Sharp & Dohme (New Zealand) Limited
Manufacturers:
Merck Sharp & Dohme Corp, Florida, United States of America
Schering-Plough SA, Madrid, Spain

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).

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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 – 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).

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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2013, No 143





✨ LLM interpretation of page content

🏥 Consent to Distribution of Nitro-Dur Medicines

🏥 Health & Social Welfare
9 October 2013
Medicines Act 1981, New Medicines, Nitro-Dur, Glyceryl trinitrate, Transdermal patch
  • Dr Don Mackie, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health

🏥 Consent to Distribution of Various New Medicines

🏥 Health & Social Welfare
9 October 2013
Medicines Act 1981, New Medicines, Betahistine, Fluoxetine, Methadone
  • Dr Don Mackie, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health