✨ Consent to Distribution of New Medicines




NEW ZEALAND GAZETTE, No. 8 β€” 26 JANUARY 2017

Product:
Active Ingredient:
Atorvastatin
Dosage Form:
Atorvastatin calcium trihydrate 86.6mg equivalent to atorvastatin 80mg
Film coated tablet
New Zealand Sponsor:
PSM Healthcare Limited trading as API Consumer Brands
Manufacturer:
Ind-Swift Limited, Punjab, India

Product:
Active Ingredient:
Loniten
Dosage Form:
Minoxidil 10mg
Tablet
New Zealand Sponsor:
Pfizer New Zealand Limited
Manufacturer:
Patheon Inc, Whitby, Canada

Dated this 20th day of January 2017.

CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).

2017-go295

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 which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:

Schedule

Product:
Active Ingredient:
Champix
Dosage Form:
Varenicline tartrate 0.85mg equivalent to varenicline 0.5mg
Film coated tablet
New Zealand Sponsor:
Pfizer New Zealand Limited
Manufacturer:
R-Pharm Germany GmbH, Illertissen, Germany

Product:
Active Ingredient:
Champix
Dosage Form:
Varenicline tartrate 1.71mg equivalent to varenicline 1mg
Film coated tablet
New Zealand Sponsor:
Pfizer New Zealand Limited
Manufacturer:
R-Pharm Germany GmbH, Illertissen, Germany

Product:
Champix 0.5mg and 1mg tablets (Combination Product)
Active Ingredient:
Varenicline tartrate 0.85mg equivalent to varenicline 0.5mg
Dosage Form:
Film coated tablet
Active Ingredient:
Varenicline tartrate 1.71mg equivalent to varenicline 1mg
Dosage Form:
Film coated tablet
New Zealand Sponsor:
Pfizer New Zealand Limited
Manufacturers:
R-Pharm Germany GmbH, Illertissen, Germany

Product:
Active Ingredient:
Creon 10,000
Dosage Form:
Pancreatin 150mg equivalent to amylase 8,000 Ph Eur U,
lipase 10,000 Ph Eur U, total protease 600 Ph Eur U
Modified release capsule
New Zealand Sponsor:
BGP Products
Manufacturer:
Abbott Laboratories GmbH, Neustadt, Germany

Product:
Active Ingredient:
Creon 25,000
Dosage Form:
Pancreatin 300mg equivalent to amylase 18,000 Ph Eur U,
lipase 25,000 Ph Eur U, total protease 1,000 Ph Eur U
Modified release capsule
New Zealand Sponsor:
BGP Products
Manufacturer:
Abbott Laboratories GmbH, Neustadt, Germany

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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2017, No 8





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of New Medicines (continued from previous page)

πŸ₯ Health & Social Welfare
20 January 2017
Medicines, Distribution, Consent, Atorvastatin, Minoxidil, Varenicline, Pancreatin, Pharmaceuticals
  • CHRIS JAMES, Group Manager, Medsafe, Ministry of Health