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: | Humira |
| Active Ingredient: | Adalimumab 10mg |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | AbbVie Limited |
| Manufacturer: | Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany |
| Product: | Humira |
| Active Ingredient: | Adalimumab 20mg |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | AbbVie Limited |
| Manufacturer: | Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany |
| Product: | Humira (20mg/0.2mL) |
| Active Ingredient: | Adalimumab 100mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | AbbVie Limited |
| Manufacturer: | Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany |
| Product: | Humira (40mg/0.4mL) |
| Active Ingredient: | Adalimumab 100mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | AbbVie Limited |
| Manufacturers: | Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany AbbVie Biotechnology Limited, Barceloneta, Puerto Rico |
| Product: | Humira (40mg/0.8mL) |
| Active Ingredient: | Adalimumab 50mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | AbbVie Limited |
| Manufacturers: | Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany |
| Product: | Humira (80mg/0.8mL) |
| Active Ingredient: | Adalimumab 100mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | AbbVie Limited |
| Manufacturers: | Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany AbbVie Biotechnology Limited, Barceloneta, Puerto Rico |
| Product: | Humira (40mg/0.4mL Pen) |
| Active Ingredient: | Adalimumab 100mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | AbbVie Limited |
| Manufacturers: | Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany AbbVie Biotechnology Limited, Barceloneta, Puerto Rico |
| Product: | Humira (40mg/0.8mL Pen) |
| Active Ingredient: | Adalimumab 50mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | AbbVie Limited |
| Manufacturers: | Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany Aesica Queenborough Limited, Queenborough, United Kingdom Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany |
| Product: | Humira (80mg/0.8mL Pen) |
| Active Ingredient: | Adalimumab 100mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | AbbVie Limited |
| Manufacturers: | Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany AbbVie Biotechnology Limited, Barceloneta, Puerto Rico |
| Product: | Miacalcic |
| Active Ingredient: | Salcatonin 100IU/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Emerge Health New Zealand Limited |
| Manufacturer: | Novartis Pharma Stein AG, Stein, Switzerland |
| Product: | Nizoral 1% |
| Active Ingredient: | Ketoconazole 10mg/mL |
| Dosage Form: | Shampoo |
| New Zealand Sponsor: | Johnson & Johnson (New Zealand) Limited |
| Manufacturer: | Janssen Pharmaceutica NV, Beerse, Belgium |
Dated this 15th day of June 2020.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).