✨ Medicines and Financial Reporting Approvals




NEW ZEALAND GAZETTE, No. 63 β€” 14 JULY 2016

Product:
Neupogen

Active Ingredient:
Filgrastim 960mcg/mL

Dosage Form:
Solution for injection

New Zealand Sponsor:
Amgen New Zealand Limited

Manufacturers:
F Hoffmann-La Roche Limited, Basel, Switzerland
F Hoffmann-La Roche Limited, Kaiseraugst, Switzerland
Amgen Manufacturing Limited, Juncos, Puerto Rico

Dated this 7th day of July 2016.

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

2016-go4008

Renewal of Provisional Consent to the Distribution of Medicines

Pursuant to section 23(4A) of the Medicines Act 1981, the Minister of Health hereby renews the provisional consent to the sale, supply or use in New Zealand of the medicines set out in the Schedule hereto:

Schedule

Product:
Mitomycin for Injection

Active Ingredient:
Mitomycin 5mg

Dosage Form:
Powder for injection

New Zealand Sponsor:
Actavis New Zealand Limited

Manufacturer:
Intas Pharmaceuticals Limited, Ahmedabad, India

Note: This renewed consent is valid for two years from 28 October 2016.

Product:
Mitomycin for Injection

Active Ingredient:
Mitomycin 20mg

Dosage Form:
Powder for injection

New Zealand Sponsor:
Actavis New Zealand Limited

Manufacturer:
Intas Pharmaceuticals Limited, Ahmedabad, India

Note: This renewed consent is valid for two years from 28 October 2016.

Dated this 7th day of July 2016.

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

2016-go4009

Approval of Qualified Persons for the Purposes of Section 36(1)(d)(ii) of the Financial Reporting Act 2013

I am satisfied that the individuals named below satisfy the requirements prescribed for the purposes of section 36A(2)(a) of the Financial Reporting Act 2013 and pursuant to section 36(1)(d)(ii) of that Act, I approve:

Ching, Weng Wee, of Perth, Australia, ASIC Registered Auditor No. 306044 and a member of Chartered Accountants Australia and New Zealand

Dizon, Jennifer K. of San Jose, United States of America, California Board of Accountancy, Registered Auditor No. 65296 and a member of American Institute of Certified Public Accountants

Flynn, Cameron James of Sydney, Australia, ASIC Registered Auditor No. 337316 and a member of Chartered Accountants Australia and New Zealand

Harnam, Kerpal Singh of Melbourne, Australia, ASIC Registered Auditor No. 365612 and a member of Chartered Accountants Australia and New Zealand

Lane, Robert Andrew of Brisbane, Australia, ASIC Registered Auditor No. 16453 and a member of Chartered Accountants Australia and New Zealand

Newman, David Foster of Dandenong, Australia, ASIC Registered Auditor No. 425804 and a member of Chartered Accountants Australia and New Zealand

Simkin, Travis John of Hawthorn East, Australia, ASIC Registered Auditor No. 477615 and a member of Chartered Accountants Australia and New Zealand

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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2016, No 63





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of Neupogen

πŸ₯ Health & Social Welfare
7 July 2016
Medicines, Distribution, Filgrastim, Amgen New Zealand
  • CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health

πŸ₯ Renewal of Provisional Consent to the Distribution of Mitomycin for Injection

πŸ₯ Health & Social Welfare
7 July 2016
Medicines, Distribution, Mitomycin, Actavis New Zealand
  • CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health

πŸ’° Approval of Qualified Persons for Financial Reporting

πŸ’° Finance & Revenue
Financial Reporting, Auditors, Approval, Chartered Accountants
7 names identified
  • Weng Wee Ching, Approved as Qualified Person
  • Jennifer K. Dizon, Approved as Qualified Person
  • Cameron James Flynn, Approved as Qualified Person
  • Kerpal Singh Harnam, Approved as Qualified Person
  • Robert Andrew Lane, Approved as Qualified Person
  • David Foster Newman, Approved as Qualified Person
  • Travis John Simkin, Approved as Qualified Person