Medicines Distribution Consent




NEW ZEALAND GAZETTE, No. 71 — 6 JULY 2017

New Zealand of the new medicines set out in the Schedule hereto:

Schedule

Product:
Akynzeo

Active Ingredients:
Palonosetron hydrochloride 0.56mg
equivalent to palonosetron 0.5mg
Netupitant 300mg

Dosage Form:
Combination capsule

New Zealand Sponsor:
Mundipharma New Zealand Limited

Manufacturer:
Helsinn Birex Pharmaceuticals Limited, Dublin, Ireland

Product:
Bosentan Dr Reddy’s

Active Ingredient:
Bosentan monohydrate 64.541mg
equivalent to bosentan 62.5mg

Dosage Form:
Film coated tablet

New Zealand Sponsor:
Dr Reddy’s New Zealand Limited

Manufacturer:
Dr Reddy’s Laboratories Limited, Bachupally, India

Product:
Bosentan Dr Reddy’s

Active Ingredient:
Bosentan monohydrate 129.082mg
equivalent to bosentan 125mg

Dosage Form:
Film coated tablet

New Zealand Sponsor:
Dr Reddy’s New Zealand Limited

Manufacturer:
Dr Reddy’s Laboratories Limited, Bachupally, India

Product:
Nicorette QuickMist

Active Ingredient:
Nicotine 13.6mg/mL

Dosage Form:
Oral spray

New Zealand Sponsor:
Johnson & Johnson (New Zealand) Limited

Manufacturer:
McNeil AB, Helsingborg, Sweden

Dated this 3rd day of July 2017.

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

2017-go3432

06-07-2017 00:00


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:
Apo-Bromocriptine

Active Ingredient:
Bromocriptine mesilate 2.9mg
equivalent to bromocriptine 2.5mg

Dosage Form:
Tablet

New Zealand Sponsor:
Apotex NZ Limited

Manufacturer:
Apotex Inc, Weston, Canada

Product:
Colofac

Active Ingredient:
Mebeverine hydrochloride 135mg

Dosage Form:
Tablet

New Zealand Sponsor:
BGP Products

Manufacturer:
Mylan Laboratories SAS, Chatillon sur Charlaronne, France

Product:
Keytruda

Active Ingredient:
Pembrolizumab 50mg

Dosage Form:
Powder for infusion

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

Manufacturer:
MSD International GmbH, Innishannon, Ireland

Dated this 3rd day of July 2017.

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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2017, No 71





✨ LLM interpretation of page content

🏥 Consent to the Distribution of New Medicines (continued from previous page)

🏥 Health & Social Welfare
3 July 2017
Medicines, Distribution, Medicines Act 1981, New Medicines
  • CHRIS JAMES, Group Manager, Medsafe, Ministry of Health