Medicines Distribution Consents




NEW ZEALAND GAZETTE, No. 68 — 18 JUNE 2015

the Class Order; and

  • the exemptions address the particular difficulties experienced by Australian incorporated companies that carry on business in New Zealand, and that have been granted relief under the Class Order from the requirement to prepare stand-alone parent company financial statements in Australia. The exemptions are not broader than what is reasonably necessary to address these difficulties and still require that consolidated financial statements be filed in New Zealand.

Dated this 18th day of June 2015.

This notice is administered by the Registrar of Companies.

2015-go3563

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:
Ezetimibe Sandoz
Active Ingredient:
Ezetimibe 10mg
Dosage Form:
Tablet
New Zealand Sponsor:
Novartis New Zealand Limited
Manufacturer:
Lek Pharmaceuticals d.d., Ljubljana, Slovenia

Product:
Triumeq
Active Ingredients:
Abacavir sulfate 702mg equivalent to Abacavir 600mg
Dolutegravir sodium 52.6mg equivalent to Dolutegravir 50mg
Lamivudine 300mg
Dosage Form:
Film coated tablet
New Zealand Sponsor:
GlaxoSmithKline (NZ) Limited
Manufacturer:
Glaxo Operations UK Limited (t/a Glaxo Wellcome Operations), Hertfordshire, United Kingdom

Dated this 12th day of June 2015.

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

2015-go3569

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:
Stelara
Active Ingredient:
Ustekinumab 45mg
Dosage Form:
Solution for injection
New Zealand Sponsor:
Janssen-Cilag (New Zealand) Limited
Manufacturers:
Cilag AG, Schaffhausen, Switzerland
Baxter Pharmaceutical Solutions LLC, Indiana, United States of America

Product:
Stelara
Active Ingredient:
Ustekinumab 90mg
Dosage Form:
Solution for injection
New Zealand Sponsor:
Janssen-Cilag (New Zealand) Limited
Manufacturers:
Cilag AG, Schaffhausen, Switzerland
Baxter Pharmaceutical Solutions LLC, Indiana, United States of America

Dated this 12th day of June 2015.

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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2015, No 68





✨ LLM interpretation of page content

🏭 Companies Act (Overseas Incorporated Companies—Australian Wholly-owned Entities) Exemption Notice 2015 (continued from previous page)

🏭 Trade, Customs & Industry
18 June 2015
Companies Act, Overseas Companies, Australian Entities, Financial Statements, Exemption
  • Registrar of Companies

🏥 Consent to the Distribution of New Medicines

🏥 Health & Social Welfare
12 June 2015
Medicines, Distribution, Ezetimibe Sandoz, Triumeq, Novartis, GlaxoSmithKline
  • CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health

🏥 Consent to the Distribution of New Medicines

🏥 Health & Social Welfare
12 June 2015
Medicines, Distribution, Stelara, Ustekinumab, Janssen-Cilag
  • CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health