New Zealand Gazette – 2005 – No. 56

Page 1436

✨ Medicines Approval Notices

1436 NEW ZEALAND GAZETTE, No. 56 24 MARCH 2005

Product:
Active Ingredient:
Papaverine hydrochloride
Dosage Form:
Papaverine hydrochloride 30mg/mL
Solution for injection
New Zealand Sponsor:
Mayne Pharma Pty Limited
Manufacturer:
Mayne Pharma Pty Limited, Mulgrave North, Victoria, Australia

Product:
Active Ingredient:
Singulair
Montelukast sodium 4.16mg equivalent to 4mg montelukast free acid
Dosage Form:
Chewable tablet
New Zealand Sponsor:
Merck Sharp & Dohme (New Zealand) Limited
Manufacturers:
Merck & Co Inc, Wilson, North Carolina, United States of America
Merck Sharp & Dohme UK Limited, Cramlington, Northumberland, United Kingdom

Product:
Active Ingredient:
Singulair
Montelukast sodium 5.2mg equivalent to 5mg montelukast free acid
Dosage Form:
Chewable tablet
New Zealand Sponsor:
Merck Sharp & Dohme (New Zealand) Limited
Manufacturers:
Merck & Co Inc, Wilson, North Carolina, United States of America
Merck Sharp & Dohme UK Limited, Cramlington, Northumberland, United Kingdom
Merck Sharp and Dohme Australia Pty Limited, South Granville, New South Wales, Australia

Product:
Active Ingredient:
Singulair
Montelukast sodium 10.4mg equivalent to 10mg montelukast free acid
Dosage Form:
Film coated tablet
New Zealand Sponsor:
Merck Sharp & Dohme (New Zealand) Limited
Manufacturers:
Merck & Co Inc, Wilson, North Carolina, United States of America
Merck Sharp & Dohme UK Limited, Cramlington, Northumberland, United Kingdom
Merck Sharp and Dohme Australia Pty Limited, South Granville, New South Wales, Australia

Dated this 18th day of March 2005.

DON MATHESON, Deputy Director-General, Public 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:
Coldsorax
Active Ingredient:
Aciclovir 5%w/w
Dosage Form:
Topical cream
New Zealand Sponsor:
PSM Healthcare Limited
Manufacturer:
Soul Pattinson Manufacturing Pty Limited, Kingsgrove, New South Wales, Australia

Product:
GONAL-f 150 for Injection
Active Ingredient:
Follitropin alpha 150IU equiv to 10.92µg/mL
Dosage Form:
Powder for injection
New Zealand Sponsor:
Douglas Pharmaceuticals Limited
Manufacturers:
Industria Farmaceutica Serono SpA, Modugno, Bari, Italy
Laboratoires Serono SA, l’Ouriettaz, Aubonne, Switzerland

Product:
GONAL-f 37.5 for Injection
Active Ingredient:
Follitropin alpha 37.5IU equiv to 2.73µg/mL
Dosage Form:
Powder for injection
New Zealand Sponsor:
Douglas Pharmaceuticals Limited
Manufacturers:
Industria Farmaceutica Serono SpA, Modugno, Bari, Italy
Laboratoires Serono SA, l’Ouriettaz, Aubonne, Switzerland

Product:
GONAL-f 75 for Injection
Active Ingredient:
Follitropin alpha 75IU equiv to 5.46µg/mL
Dosage Form:
Powder for injection
New Zealand Sponsor:
Douglas Pharmaceuticals Limited
Manufacturers:
Industria Farmaceutica Serono SpA, Modugno, Bari, Italy
Laboratoires Serono SA, l’Ouriettaz, Aubonne, Switzerland

Dated this 18th day of March 2005.

DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).

go1787

VUW Te Waharoa — NZ Gazette 2005, No 56

Gazette.govt.nz — NZ Gazette 2005, No 56

Parliament House (depicted) was completed in 1918 and remains the primary seat of Parliament.

✨ LLM interpretation of page content

🏥 Consent to the Distribution of Changed Medicines (continued from previous page)

Domain🏥 Health & Social Welfare
Dated18 March 2005
KeywordsMedicines Act 1981, Papaverine Hydrochloride, Mayne Pharma Pty Limited
👩‍💼 Officials

DON MATHESON, Deputy Director-General, Public Health

🏥 Consent to the Distribution of New Medicines

Domain🏥 Health & Social Welfare
Dated18 March 2005
KeywordsMedicines Act 1981, Coldsorax, GONAL-f, Aciclovir, Follitropin alpha
👩‍💼 Officials

DON MATHESON, Deputy Director-General, Public Health

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