Gazette.govt.nzPursuant 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: | Bactol Blue |
| Active Ingredient: | Ethanol 62.58%w/w equivalent to absolute ethanol 70%v/v |
| Dosage Form: | Topical gel |
| New Zealand Sponsor: | Whiteley Corporation (NZ) |
| Manufacturer: | Felton Grimwade & Bosisto’s Pty Limited, Melbourne, Australia |
| Product: | Entecavir |
| Active Ingredient: | Entecavir monohydrate 0.533mg equivalent to entecavir 0.50mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Teva Pharma (New Zealand) Limited |
| Manufacturer: | PLIVA Croatia Limited., Zagreb, Croatia |
| Product: | Entecavir |
| Active Ingredient: | Entecavir monohydrate 1.065mg equivalent to entecavir 1mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Teva Pharma (New Zealand) Limited |
| Manufacturer: | PLIVA Croatia Limited., Zagreb, Croatia |
| Product: | Erlotinib Dr.Reddy’s |
| Active Ingredient: | Erlotinib hydrochloride 27.317mg equivalent to erlotinib 25mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Dr Reddy’s New Zealand Limited |
| Manufacturer: | Dr Reddy’s Laboratories Limited, Visakhapatnam, India |
| Product: | Erlotinib Dr.Reddy’s |
| Active Ingredient: | Erlotinib hydrochloride 109.267mg equivalent to erlotinib 100mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Dr Reddy’s New Zealand Limited |
| Manufacturer: | Dr Reddy’s Laboratories Limited, Visakhapatnam, India |
| Product: | Erlotinib Dr.Reddy’s |
| Active Ingredient: | Erlotinib hydrochloride 163.9mg equivalent to erlotinib 150mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Dr Reddy’s New Zealand Limited |
| Manufacturer: | Dr Reddy’s Laboratories Limited, Visakhapatnam, India |
| Product: | Fasenra Pen |
| Active Ingredient: | Benralizumab 30mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | AstraZeneca Limited |
| Manufacturers: | AstraZeneca Pharmaceuticals LP,Maryland, United States of America Catalent Indiana LLC, Indiana, United States of America |
Dated this 9th day of August 2022.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).