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: | Meropenem Kabi |
| Active Ingredient: | Meropenem trihydrate 570mg equivalent to meropenem 500mg |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | Fresenius Kabi New Zealand Limited |
| Manufacturer: | ACS Dobfar SpA, Teramo, Italy |
| Product: | Meropenem Kabi |
| Active Ingredient: | Meropenem trihydrate 1140mg equivalent to meropenem 1000mg |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | Fresenius Kabi New Zealand Limited |
| Manufacturer: | ACS Dobfar SpA, Teramo, Italy |
| Product: | Paliperidone-Teva (25mg/0.25mL) |
| Active Ingredient: | Paliperidone palmitate 156mg/mL equivalent to paliperidone 100mg/ml |
| Dosage Form: | Suspension for injection |
| New Zealand Sponsor: | Teva Pharma (New Zealand) Limited |
| Manufacturer: | Teva Pharmaceutical Industries Limited, Kfar Saba, Israel |
| Product: | Paliperidone-Teva (50mg/0.5mL) |
| Active Ingredient: | Paliperidone palmitate 156mg/mL equivalent to paliperidone 100mg/ml |
| Dosage Form: | Suspension for injection |
| New Zealand Sponsor: | Teva Pharma (New Zealand) Limited |
| Manufacturer: | Teva Pharmaceutical Industries Limited, Kfar Saba, Israel |
| Product: | Paliperidone-Teva (75mg/0.75mL) |
| Active Ingredient: | Paliperidone palmitate 156mg/mL equivalent to paliperidone 100mg/ml |
| Dosage Form: | Suspension for injection |
| New Zealand Sponsor: | Teva Pharma (New Zealand) Limited |
| Manufacturer: | Teva Pharmaceutical Industries Limited, Kfar Saba, Israel |
| Product: | Paliperidone-Teva (100mg/1mL) |
| Active Ingredient: | Paliperidone palmitate 156mg/mL equivalent to paliperidone 100mg/ml |
| Dosage Form: | Suspension for injection |
| New Zealand Sponsor: | Teva Pharma (New Zealand) Limited |
| Manufacturer: | Teva Pharmaceutical Industries Limited, Kfar Saba, Israel |
| Product: | Paliperidone-Teva (150mg/1.5mL) |
| Active Ingredient: | Paliperidone palmitate 156mg/mL equivalent to paliperidone 100mg/ml |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Teva Pharma (New Zealand) Limited |
| Manufacturer: | Teva Pharmaceutical Industries Limited, Kfar Saba, Israel |
Dated this 23rd day of April 2021.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).