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-Ursodeoxycholic Acid |
| Active Ingredient: | Ursodeoxycholic acid 250mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Apotex NZ Limited |
| Manufacturer: | Joint Stock Company “Grindeks”, Riga, Latvia |
| Product: | INOVELON |
| Active Ingredient: | Rufinamide 100mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Eisai New Zealand Limited |
| Manufacturer: | Bushu Pharmaceuticals Limited, Saitama-Ken, Japan |
| Product: | INOVELON |
| Active Ingredient: | Rufinamide 200mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Eisai New Zealand Limited |
| Manufacturer: | Bushu Pharmaceuticals Limited, Saitama-Ken, Japan |
| Product: | INOVELON |
| Active Ingredient: | Rufinamide 400mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Eisai New Zealand Limited |
| Manufacturer: | Bushu Pharmaceuticals Limited, Saitama-Ken, Japan |
| Product: | Purell Antiseptic Hand Foam |
| Active Ingredient: | Ethanol 63.7255%w/w |
| Dosage Form: | Foam |
| New Zealand Sponsor: | CARSL Consulting |
| Manufacturer: | Pax Australia Pty Limited, Sydney, Australia |
| Product: | Purell Antiseptic Hand Gel |
| Active Ingredient: | Ethanol 65.275%w/w |
| Dosage Form: | Topical gel |
| New Zealand Sponsor: | CARSL Consulting |
| Manufacturer: | Pax Australia Pty Limited, Sydney, Australia |
| Product: | Rozlytrek |
| Active Ingredient: | Entrectinib 100mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Roche Products (NZ) Limited |
| Manufacturer: | Mayne Pharma Inc, North Carolina, United States of America |
| Product: | Rozlytrek |
| Active Ingredient: | Entrectinib 200mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Roche Products (NZ) Limited |
| Manufacturer: | Mayne Pharma Inc, North Carolina, United States of America |
| Product: | Voke Inhaler |
| Active Ingredient: | Nicotine 0.448mg per dose |
| Dosage Form: | Aerosol inhaler, metered dose |
| New Zealand Sponsor: | Nicovations New Zealand Limited |
| Manufacturers: | Pharmaserve (North West) Limited, Runcorn, United Kingdom Bespak Europe Limited, King’s Lynn, United Kingdom |
Dated this 8th day of June 2020.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).