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: | Afluria Quad Junior |
| Active Ingredients: | Influenza virus A/Michigan/45/2015 (H1N1) pdm09 – like strain 7.5mcg Influenza virus A/Switzerland/8060/2017 (H3N2) – like strain 7.5mcg Influenza virus B/Colorado/06/2017 – like strain 7.5mcg Influenza virus B/Phuket/3073/2013 – like strain 7.5mcg |
| Dosage Form: | Suspension for injection |
| New Zealand Sponsor: | Seqirus (NZ) Limited |
| Manufacturer: | Seqirus Pty Limited, Melbourne, Australia |
| Product: | Revestive |
| Active Ingredient: | Teduglutide 5mg |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | Shire New Zealand Limited |
| Manufacturer: | Patheon Italia SpA, Milan, Italy |
| Product: | Spravato |
| Active Ingredient: | Esketamine hydrochloride 161.4mg/mL equivalent to esketamine 140mg/mL |
| Dosage Form: | Nasal spray solution |
| New Zealand Sponsor: | Janssen-Cilag (New Zealand) Limited |
| Manufacturer: | Renaissance Lakewood LLC, New Jersey, United States of America |
| Product: | Tigecycline Juno |
| Active Ingredient: | Tigecycline 50mg |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | Neo Health (NZ) Limited |
| Manufacturer: | Gland Pharma Limited, Andhra Pradesh, India |
Dated this 12th day of December 2019.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).