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).