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: | Dapagliflozin |
| Active Ingredient: | Dapagliflozin 10mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Teva Pharma (New Zealand) Limited |
| Manufacturer: | Watson Pharma Private Limited, Verna, India |
| Product: | Hadlima |
| Active Ingredient: | Adalimumab 50mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Samsung Bioepis NZ Limited |
| Manufacturers: | Catalent Belgium SA, Brussels, Belgium Catalent Indiana LLC, Indiana, United States of America |
| Product: | Hadlima PushTouch |
| Active Ingredient: | Adalimumab 50mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Samsung Bioepis NZ Limited |
| Manufacturers: | Catalent Belgium SA, Brussels, Belgium Catalent Indiana LLC, Indiana, United States of America |
| Product: | SCEMBLIX |
| Active Ingredient: | Asciminib 20mg equivalent to asciminib hydrochloride 21.62mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Novartis Pharma Stein AG, Stein, Switzerland |
| Product: | SCEMBLIX |
| Active Ingredient: | Asciminib 40mg equivalent to asciminib hydrochloride 43.24mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Novartis Pharma Stein AG, Stein, Switzerland |
Dated this 9th day of February 2024.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).