Notice Type
Departmental
Notice Title

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 set out in the Schedule hereto:

Schedule

Product: Cefalexin
Active Ingredient: Cefalexin monohydrate 26.295mg/mL equivalent to cefalexin 25mg/mL
Dosage Form: Oral granules
New Zealand Sponsor: Max Health Limited
Manufacturer: ACS Dobfar SpA, Pomezia, Italy
   
Product: Cefalexin
Active Ingredient: Cefalexin monohydrate 52.591mg/mL equivalent to cefalexin 50mg/mL
Dosage Form: Oral granules
New Zealand Sponsor: Max Health Limited
Manufacturer: ACS Dobfar SpA, Pomezia, Italy
   
Product: Fulvestrant-Teva
Active Ingredient: Fulvestrant 50mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Teva Pharma (New Zealand) Limited
Manufacturer: PLIVA Croatia Limited, Zagreb, Croatia
   
Product: MYLOTARG
Active Ingredient: Gemtuzumab ozogamicin 5mg
Dosage Form: Powder for injection
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Wyeth Pharmaceutical Division of Wyeth Holdings LLC, New York, United States of America


Dated this 10th day of November 2021.

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