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: | DBL™ Bortezomib |
| Active Ingredient: | Bortezomib 2.5mg |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturer: | Gland Pharma Limited, Visakhapatnam, India |
| Product: | DBL™ Bortezomib |
| Active Ingredient: | Bortezomib 3mg |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturer: | Gland Pharma Limited, Visakhapatnam, India |
| Product: | DBL™ Bortezomib |
| Active Ingredient: | Bortezomib 3.5mg |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturer: | Gland Pharma Limited, Visakhapatnam, India |
| Product: | Hospira™ Bortezomib |
| Active Ingredient: | Bortezomib 2.5mg |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturer: | Gland Pharma Limited, Visakhapatnam, India |
| Product: | Hospira™ Bortezomib |
| Active Ingredient: | Bortezomib 3mg |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturer: | Gland Pharma Limited, Visakhapatnam, India |
| Product: | Hospira™ Bortezomib |
| Active Ingredient: | Bortezomib 3.5mg |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturer: | Gland Pharma Limited, Visakhapatnam, India |
| 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 (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 (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: | Juluca |
| Active Ingredients: | Dolutegravir sodium 52.62mg equivalent to dolutegravir 50mg Rilpivirine hydrochloride 27.5mg equivalent to rilpivirine 25mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | GlaxoSmithKline (NZ) Limited |
| Manufacturer: | Glaxo Operations UK Limited t/a Glaxo Welcome Operations, Hertfordshire, United Kingdom |
Dated this 23rd day of September 2019.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).