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: | Apo-Ondansetron ODT |
| Active Ingredient: | Ondansetron 4mg |
| Dosage Form: | Orodispersible tablet |
| New Zealand Sponsor: | Ipca Pharma (NZ) Pty Limited |
| Manufacturer: | Ipca Laboratories Limited, Silvassa, India |
| Product: | Apo-Ondansetron ODT |
| Active Ingredient: | Ondansetron 8mg |
| Dosage Form: | Orodispersible tablet |
| New Zealand Sponsor: | Ipca Pharma (NZ) Pty Limited |
| Manufacturer: | Ipca Laboratories Limited, Silvassa, India |
| Product: | Bortezomib |
| Active Ingredient: | Bortezomib 3.5mg |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | REX Medical Limited |
| Manufacturer: | MSN Laboratories Private Limited, Nandigama, India |
| Product: | Bortezomib Juno |
| Active Ingredient: | Bortezomib 1mg |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | Juno Pharmaceuticals NZ Limited |
| Manufacturer: | Oncomed manufacturing a.s., Brno, Czech Republic |
| Product: | Bortezomib Juno |
| Active Ingredient: | Bortezomib 3.5mg |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | Juno Pharmaceuticals NZ Limited |
| Manufacturer: | Oncomed manufacturing a.s., Brno, Czech Republic |
| Product: | Bupivacaine spinal heavy BNM |
| Active Ingredient: | Bupivacaine hydrochloride monohydrate 5.28mg/mL equivalent to bupivacaine hydrochloride 5mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Boucher & Muir (New Zealand) Limited t/a BNM Group |
| Manufacturer: | Sintetica SA, Mendrisio, Switzerland |
| Product: | Ipca-Ondansetron ODT |
| Active Ingredient: | Ondansetron 4mg |
| Dosage Form: | Orodispersible tablet |
| New Zealand Sponsor: | Ipca Pharma (NZ) Pty Limited |
| Manufacturer: | Ipca Laboratories Limited, Silvassa, India |
| Product: | Ipca-Ondansetron ODT |
| Active Ingredient: | Ondansetron 8mg |
| Dosage Form: | Orodispersible tablet |
| New Zealand Sponsor: | Ipca Pharma (NZ) Pty Limited |
| Manufacturer: | Ipca Laboratories Limited, Silvassa, India |
| Product: | Periset ODT |
| Active Ingredient: | Ondansetron 4mg |
| Dosage Form: | Orodispersible tablet |
| New Zealand Sponsor: | Ipca Pharma (NZ) Pty Limited |
| Manufacturer: | Ipca Laboratories Limited, Silvassa, India |
| Product: | Periset ODT |
| Active Ingredient: | Ondansetron 8mg |
| Dosage Form: | Orodispersible tablet |
| New Zealand Sponsor: | Ipca Pharma (NZ) Pty Limited |
| Manufacturer: | Ipca Laboratories Limited, Silvassa, India |
| Product: | Posaconazole |
| Active Ingredient: | Posaconazole 40mg/mL |
| Dosage Form: | Oral suspension |
| New Zealand Sponsor: | Devatis Limited |
| Manufacturer: | Deva Holding AS, Tekirdag, Turkey |
| Product: | Vimpat |
| Active Ingredient: | Lacosamide 10mg/mL |
| Dosage Form: | Oral solution |
| New Zealand Sponsor: | Seqirus (NZ) Limited |
| Manufacturer: | Unither Manufacturing LLC, New York, United States of America |
Dated this 14th day of April 2020.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).