Notice Type
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 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:


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).