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: | Beovu (27.6mg/0.23mL) |
| Active Ingredient: | Brolucizumab 120mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Novartis Pharma Stein AG, Stein, Switzerland |
| Product: | Beovu (Pre-filled syringe 19.8mg/0.165mL) |
| Active Ingredient: | Brolucizumab 120mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Alcon Couvreur NV, Puurs, Belgium |
| Product: | Buvidal Monthly (64mg/ 0.18mL) |
| Active Ingredient: | Buprenorphine 356mg/mL |
| Dosage Form: | Injection (depot) |
| New Zealand Sponsor: | CARSL Consulting |
| Manufacturer: | Rechon Life Science AB, Limhamn, Sweden |
| Product: | Buvidal Monthly (96mg/0.27mL) |
| Active Ingredient: | Buprenorphine 356mg/mL |
| Dosage Form: | Injection (depot) |
| New Zealand Sponsor: | CARSL Consulting |
| Manufacturer: | Rechon Life Science AB, Limhamn, Sweden |
| Product: | Buvidal Monthly (128mg/0.36mL) |
| Active Ingredient: | Buprenorphine 356mg/mL |
| Dosage Form: | Injection (depot) |
| New Zealand Sponsor: | CARSL Consulting |
| Manufacturer: | Rechon Life Science AB, Limhamn, Sweden |
| Product: | Buvidal Weekly (8mg/0.16mL) |
| Active Ingredient: | Buprenorphine 50mg/mL |
| Dosage Form: | Injection (depot) |
| New Zealand Sponsor: | CARSL Consulting |
| Manufacturer: | Rechon Life Science AB, Limhamn, Sweden |
| Product: | Buvidal Weekly (16mg/0.32mL) |
| Active Ingredient: | Buprenorphine 50mg/mL |
| Dosage Form: | Injection (depot) |
| New Zealand Sponsor: | CARSL Consulting |
| Manufacturer: | Rechon Life Science AB, Limhamn, Sweden |
| Product: | Buvidal Weekly (24mg/0.48mL) |
| Active Ingredient: | Buprenorphine 50mg/mL |
| Dosage Form: | Injection (depot) |
| New Zealand Sponsor: | CARSL Consulting |
| Manufacturer: | Rechon Life Science AB, Limhamn, Sweden |
| Product: | Buvidal Weekly (32mg/0.64mL) |
| Active Ingredient: | Buprenorphine 50mg/mL |
| Dosage Form: | Injection (depot) |
| New Zealand Sponsor: | CARSL Consulting |
| Manufacturer: | Rechon Life Science AB, Limhamn, Sweden |
Dated this 20th day of January 2023.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).