✨ 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.
40
Next Page →
✨ LLM interpretation of page content
🏥
Consent to the Distribution of New Medicines
(continued from previous page)
🏥 Health & Social Welfare3 July 2017
Medicines, Distribution, Medicines Act 1981, New Medicines
- CHRIS JAMES, Group Manager, Medsafe, Ministry of Health
NZ Gazette 2017, No 71