β¨ 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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β¨ LLM interpretation of page content
π₯ Consent to the Distribution of New Medicines
π₯ Health & Social Welfare15 September 2017
Medicines, Distribution, Consent, Medicines Act 1981, Metformin, Zytiga
- CHRIS JAMES, Group Manager, Medsafe, Ministry of Health
π₯ Consent to the Distribution of a New Medicine
π₯ Health & Social Welfare15 September 2017
Medicines, Distribution, Consent, Medicines Act 1981, Synflorix
- CHRIS JAMES, Group Manager, Medsafe, Ministry of Health
π₯ Renewal of Provisional Consent to the Distribution of a Medicine
π₯ Health & Social Welfare15 September 2017
Medicines, Distribution, Provisional Consent, Renewal, Medicines Act 1981, Daunorubicin
- CHRIS JAMES, Group Manager, Medsafe, Ministry of Health
NZ Gazette 2017, No 97