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: | Maviret |
Active Ingredients: | Glecaprevir 100mg Pibrentasvir 40mg |
Dosage Form: | Film coated tablet |
New Zealand Sponsor: | AbbVie Limited |
Manufacturers: | AbbVie Deutschland GmbH & Co KG, Ludwigshafen, Germany Fournier Laboratories Ireland Limited, Carrigtwohill, Ireland |
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 |
Dated this 15th day of September 2020.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).