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: | 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: | Eurax |
| Active Ingredient: | Crotamiton 10%w/w |
| Dosage Form: | Topical cream |
| New Zealand Sponsor: | Nice-Pak Products (NZ) Limited |
| Manufacturers: | GSK Consumer Healthcare SARL, Prangins, Switzerland Thornton & Ross Limited, Huddersfield, United Kingdom |
| 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: | Sotalol |
| Active Ingredient: | Sotalol hydrochloride 80mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Viatris Limited |
| Manufacturer: | Alphapharm Pty Limited, Brisbane, Australia |
| Product: | Sotalol |
| Active Ingredient: | Sotalol hydrochloride 160mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Viatris Limited |
| Manufacturer: | Alphapharm Pty Limited, Brisbane, Australia |
Dated this 7th 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).