✨ Medicine Distribution Consents




NEW ZEALAND GAZETTE, No. 97 β€” 21 SEPTEMBER 2017

Product:
Metformin Mylan
Active Ingredient:
Metformin hydrochloride 1000mg
Dosage Form:
Film coated tablet
New Zealand Sponsor:
Mylan New Zealand Limited
Manufacturers:
Mylan Laboratories Limited, Nashik, India
Granules India Limited, Hyderabad, India

Product:
Zytiga
Active Ingredient:
Abiraterone acetate 500mg
Dosage Form:
Film coated tablet
New Zealand Sponsor:
Janssen-Cilag (New Zealand) Limited
Manufacturer:
Patheon France SA, Bourgoin Jallieu, France

Dated this 15th day of September 2017.

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

2017-go4883

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:
Synflorix
Active Ingredients:
Pneumococcal polysaccharide type 1 1mcg
Pneumococcal polysaccharide type 14 1mcg
Pneumococcal polysaccharide type 18C 3mcg
Pneumococcal polysaccharide type 19F 3mcg
Pneumococcal polysaccharide type 23F 1mcg
Pneumococcal polysaccharide type 4 3mcg
Pneumococcal polysaccharide type 5 1mcg
Pneumococcal polysaccharide type 6B 1mcg
Pneumococcal polysaccharide type 7F 1mcg
Pneumococcal polysaccharide type 9V 1mcg
Dosage Form:
Suspension for injection
New Zealand Sponsor:
GlaxoSmithKline (NZ) Limited
Manufacturers:
GlaxoSmithKline Biologicals SA, Rixensart, Belgium
GlaxoSmithKline Biologicals (France), Saint-Amand-Les-Eaux, France

Dated this 15th day of September 2017.

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

2017-go4884

Renewal of Provisional Consent to the Distribution of a Medicine

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 medicine set out in the Schedule hereto:

Schedule

Product:
Daunorubicin
Active Ingredient:
Daunorubicin hydrochloride 2.14mg/mL equivalent to daunorubicin 2mg/mL
Dosage Form:
Solution for injection
New Zealand Sponsor:
Pfizer New Zealand Limited
Manufacturer:
Pfizer (Perth) Pty Limited, Perth, Australia

Note: This renewed consent is valid for two years from 26 September 2017.

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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2017, No 97





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
15 September 2017
Medicines, Distribution, Consent, Medicines Act 1981, Metformin, Zytiga
  • CHRIS JAMES, Group Manager, Medsafe, Ministry of Health

πŸ₯ Consent to the Distribution of a New Medicine

πŸ₯ Health & Social Welfare
15 September 2017
Medicines, Distribution, Consent, Medicines Act 1981, Synflorix
  • CHRIS JAMES, Group Manager, Medsafe, Ministry of Health

πŸ₯ Renewal of Provisional Consent to the Distribution of a Medicine

πŸ₯ Health & Social Welfare
15 September 2017
Medicines, Distribution, Provisional Consent, Renewal, Medicines Act 1981, Daunorubicin
  • CHRIS JAMES, Group Manager, Medsafe, Ministry of Health