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:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
|
Hizentra
Normal immunoglobulin 200mg/mL
Solution for injection
CSL Behring (NZ) Limited
CSL Behring AG, Bern, Switzerland
|
|
Product:
Active Ingredients:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
|
Janumet
Metformin hydrochloride 500mg
Sitagliptin phosphate monohydrate 64.25mg equivalent to sitagliptin 50mg
Film coated tablet
Merck Sharp & Dohme (New Zealand) Limited
Patheon Puerto Rico Inc., Manati, Puerto Rico
Aesica Queenborough Limited, Queenborough, United Kingdom
|
|
Product:
Active Ingredients:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
|
Janumet
Metformin hydrochloride 850mg
Sitagliptin phosphate monohydrate 64.25mg equivalent to sitagliptin 50mg
Film coated tablet
Merck Sharp & Dohme (New Zealand) Limited
Patheon Puerto Rico Inc., Manati, Puerto Rico
Aesica Queenborough Limited, Queenborough, United Kingdom
|
|
Product:
Active Ingredients:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
|
Janumet
Metformin hydrochloride 1000mg
Sitagliptin phosphate monohydrate 64.25mg equivalent to sitagliptin 50mg
Film coated tablet
Merck Sharp & Dohme (New Zealand) Limited
Patheon Puerto Rico Inc., Manati, Puerto Rico
Aesica Queenborough Limited, Queenborough, United Kingdom
|
|
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
|
Januvia
Sitagliptin phosphate monohydrate 32.13mg equivalent to sitagliptin 25mg
Film coated tablet
Merck Sharp & Dohme (New Zealand) Limited
Merck Sharp & Dohme SpA, Pavia, Italy
Merck Sharp & Dohme Limited, Cramlington, United Kingdom
|
|
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
|
Januvia
Sitagliptin phosphate monohydrate 64.25mg equivalent to sitagliptin 50mg
Film coated tablet
Merck Sharp & Dohme (New Zealand) Limited
Merck Sharp & Dohme SpA, Pavia, Italy
Merck Sharp & Dohme Limited, Cramlington, United Kingdom
|
|
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
|
Januvia
Sitagliptin phosphate monohydrate 128.5mg equivalent to sitagliptin 100mg
Film coated tablet
Merck Sharp & Dohme (New Zealand) Limited
Merck Sharp & Dohme SpA, Pavia, Italy
Merck Sharp & Dohme Limited, Cramlington, United Kingdom
|
Dated this 3rd day of April 2018.
ALISON COSSAR, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).
Gazette.govt.nz