Medicines and Early Childhood Service Notices




NEW ZEALAND GAZETTE, No. 64 — 21 JULY 2016

Product:
Diclohexal 1%

Active Ingredient:
Diclofenac sodium 10mg/g

Dosage Form:
Topical gel

New Zealand Sponsor:
Novartis New Zealand Limited

Manufacturer:
PSM Healthcare Limited (trading as API Consumer Brands), Auckland

Dated this 14th 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-go4158


Consent to the Distribution of a New Medicine

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicine which was referred to the Minister of Health under the provisions of section 24(5) of the Act and is set out in the Schedule hereto:

Schedule

Product:
Gardasil 9

Active Ingredients:
Human Papillomavirus (HPV) 6 L1 Protein 30mcg
Human Papillomavirus (HPV) 11 L1 Protein 40mcg
Human Papillomavirus (HPV) 16 L1 Protein 60mcg
Human Papillomavirus (HPV) 18 L1 Protein 40mcg
Human Papillomavirus (HPV) 31 L1 Protein 20mcg
Human Papillomavirus (HPV) 33 L1 Protein 20mcg
Human Papillomavirus (HPV) 45 L1 Protein 20mcg
Human Papillomavirus (HPV) 52 L1 Protein 20mcg
Human Papillomavirus (HPV) 58 L1 Protein 20mcg

Dosage Form:
Suspension for injection

New Zealand Sponsor:
Merck Sharp & Dohme (New Zealand) Limited

Manufacturer:
Merck Sharp & Dohme Corp, Pennsylvania, United States of America

Dated this 14th 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-go4161


Corrigendum—Classification of Medicines

In the notice published in the New Zealand Gazette, 25 February 2016, Issue No. 16, Notice No. 2016-go1070, delete the following entry in Schedule 1

“Methylhexanamine (1,3-dimethylamylamine (DMAA)); except when present as an unmodified, naturally occurring medicine”

and replace with

“Methylhexanamine (1,3-dimethylamylamine (DMAA)); except when present as an unmodified, naturally occurring substance”

Dated this 14th 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-go4165


Cancellation of Licence for an Early Childhood Service

Pursuant to Regulation 32(1)(d)(i) of the Education (Early Childhood Services) Regulations 2008, and acting under authority delegated by the Secretary for Education, I hereby cancel the licence dated 15 September 2014, which was granted under those Regulations to Jennie Meacheam in respect of Alphabet Academy Central (52514),

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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2016, No 64





✨ LLM interpretation of page content

🏥 Consent to the Distribution of a New Medicine

🏥 Health & Social Welfare
14 July 2016
Medicine, Consent, Distribution, Schedule, Diclohexal 1%, Diclofenac sodium, Topical gel, Novartis New Zealand Limited
  • CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health

🏥 Consent to the Distribution of a New Medicine

🏥 Health & Social Welfare
14 July 2016
Medicine, Consent, Distribution, Schedule, Gardasil 9, Human Papillomavirus, Suspension for injection, Merck Sharp & Dohme
  • CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health

🏥 Corrigendum—Classification of Medicines

🏥 Health & Social Welfare
14 July 2016
Medicines, Classification, Corrigendum, Methylhexanamine, DMAA
  • CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health

🎓 Cancellation of Licence for an Early Childhood Service

🎓 Education, Culture & Science
14 July 2016
Early Childhood Service, Licence Cancellation, Alphabet Academy Central
  • Jennie Meacheam, Licence cancelled for Alphabet Academy Central