Medicines Approval




13 MAY 2010

NEW ZEALAND GAZETTE, No. 55

1523

Health

Medicines Act 1981

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:
Robitussin Chesty Cough & Nasal Congestion PE

Active Ingredients:
Guaifenesin 20mg/mL
Phenylephrine hydrochloride 1mg/mL

Dosage Form:
Oral solution

New Zealand Sponsor:
Pfizer New Zealand Limited

Manufacturer:
Richmond Division of Wyeth, Richmond, United States of America

Product:
Elevit with Iodine

Active Ingredients:
Biotin 0.2mg
Calcium ascorbate dihydrate 133mg
Calcium hydrogen phosphate, anhydrous 378.89mg
Calcium pantothenate 10mg
Colecalciferol 12.5µg
Copper sulphate, anhydrous 2.51mg
Cyanocobalamin 4µg
D-alpha-Tocopheryl acetate 15mg
Dibasic Magnesium phosphate trihydrate 217.95mg
Ferrous fumarate 183mg
Folic acid 800µg
Light magnesium oxide 114.42mg
Manganese sulfate monohydrate 3.08mg
Nicotinamide 19mg
Potassium iodide 0.327mg
Pyridoxine hydrochloride 2.6mg
Riboflavin 1.8mg
Thiamine nitrate 1.71mg
Zinc sulfate monohydrate 20.6mg

Dosage Form:
Film coated tablet

New Zealand Sponsor:
Bayer New Zealand Limited

Manufacturer:
Rottendorf Pharma GmbH, Ennigerloh, Germany

Product:
Famvir Once

Active Ingredients:
Famciclovir 500mg

Dosage Form:
Tablet

New Zealand Sponsor:
Novartis New Zealand Limited

Manufacturer:
Novartis Farmaceutica SA, Barcelona, Spain

Product:
Deslor

Active Ingredients:
Desloratadine 5mg

Dosage Form:
Film coated tablet

New Zealand Sponsor:
Multichem NZ Limited

Manufacturer:
Cipla Limited, Goa, India

Product:
Diff-Aid Sore Throat Gargle with Iodine Ready to Use

Active Ingredients:
Povidone-iodine 1%w/w

Dosage Form:
Oral solution

New Zealand Sponsor:
iNova Pharmaceuticals (New Zealand) Limited

Manufacturers:
Probiotec Pharma Pty Limited, Laverton North, Australia

iNova Pharmaceuticals (Australia) Pty Limited, Thornleigh, Australia

Dated this 6th day of May 2010.

MARK RICHARDS, Acting Deputy Director-General, Regulation and Governance Directorate, 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 2010, No 55





✨ LLM interpretation of page content

🏥 Consent to the Distribution of New Medicines

🏥 Health & Social Welfare
6 May 2010
Medicines, Approval, Distribution, New Zealand
  • MARK RICHARDS, Acting Deputy Director-General, Regulation and Governance Directorate, Ministry of Health