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 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: | Kadcyla |
| Active Ingredient: | Trastuzumab emtansine 100mg |
| Dosage Form: | Powder for infusion |
| New Zealand Sponsor: | Roche Products (NZ) Limited |
| Manufacturers: | Patheon Manufacturing Services LLC, North Carolina, United States of America F Hoffmann-La Roche Limited, Kaiseraugst, Switzerland |
| Product: | Kadcyla |
| Active Ingredient: | Trastuzumab emtansine 160mg |
| Dosage Form: | Powder for infusion |
| New Zealand Sponsor: | Roche Products (NZ) Limited |
| Manufacturers: | Patheon Manufacturing Services LLC, North Carolina, United States of America F Hoffmann-La Roche Limited, Kaiseraugst, Switzerland |
| Product: | Spiriva Respimat |
| Active Ingredient: | Tiotropium bromide monohydrate 3.125mcg equivalent to tiotropium 2.5mcg/dose |
| Dosage Form: | Solution for inhalation |
| New Zealand Sponsor: | Boehringer Ingelheim (NZ) Limited |
| Manufacturer: | Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany |
| Product: | Sustanon 250 |
| Active Ingredients: | Testosterone decanoate 100mg/mL Testosterone isocaproate 60mg/mL Testosterone phenylpropionate 60mg/mL Testosterone propionate 30mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturers: | NV Organon, Oss, Netherlands EVER Pharma Jena GmbH, Jena, Germany |
| Product: | Uptravi |
| Active Ingredient: | Selexipag 200mcg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Janssen-Cilag (New Zealand) Limited |
| Manufacturer: | Excella GmbH & Co KG, Feucht, Germany |
| Product: | Uptravi |
| Active Ingredient: | Selexipag 400mcg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Janssen-Cilag (New Zealand) Limited |
| Manufacturer: | Excella GmbH & Co KG, Feucht, Germany |
| Product: | Uptravi |
| Active Ingredient: | Selexipag 600mcg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Janssen-Cilag (New Zealand) Limited |
| Manufacturer: | Excella GmbH & Co KG, Feucht, Germany |
| Product: | Uptravi |
| Active Ingredient: | Selexipag 800mcg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Janssen-Cilag (New Zealand) Limited |
| Manufacturer: | Excella GmbH & Co KG, Feucht, Germany |
| Product: | Uptravi |
| Active Ingredient: | Selexipag 1000mcg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Janssen-Cilag (New Zealand) Limited |
| Manufacturer: | Excella GmbH & Co KG, Feucht, Germany |
| Product: | Uptravi |
| Active Ingredient: | Selexipag 1200mcg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Janssen-Cilag (New Zealand) Limited |
| Manufacturer: | Excella GmbH & Co KG, Feucht, Germany |
| Product: | Uptravi |
| Active Ingredient: | Selexipag 1400mcg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Janssen-Cilag (New Zealand) Limited |
| Manufacturer: | Excella GmbH & Co KG, Feucht, Germany |
| Product: | Uptravi |
| Active Ingredient: | Selexipag 1600mcg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Janssen-Cilag (New Zealand) Limited |
| Manufacturer: | Excella GmbH & Co KG, Feucht, Germany |
Dated this 14th day of October 2019.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).