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: | Ropivacaine Kabi |
| Active Ingredient: | Ropivacaine hydrochloride 2mg/mL equivalent to ropivacaine 1.77mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Fresenius Kabi New Zealand Limited |
| Manufacturer: | Fresenius Kabi Norge AS, Halden, Norway |
| Product: | Ropivacaine Kabi |
| Active Ingredient: | Ropivacaine hydrochloride 5mg/mL equivalent to ropivacaine 4.43mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Fresenius Kabi New Zealand Limited |
| Manufacturer: | Fresenius Kabi Norge AS, Halden, Norway |
| Product: | Ropivacaine Kabi |
| Active Ingredient: | Ropivacaine hydrochloride 7.5mg/mL equivalent to ropivacaine 6.64mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Fresenius Kabi New Zealand Limited |
| Manufacturer: | Fresenius Kabi Norge AS, Halden, Norway |
| Product: | Ropivacaine Kabi |
| Active Ingredient: | Ropivacaine hydrochloride 10mg/mL equivalent to ropivacaine 8.85mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Fresenius Kabi New Zealand Limited |
| Manufacturer: | Fresenius Kabi Norge AS, Halden, Norway |
| Product: | Sofradex |
| Active Ingredients: | Dexamethasone sodium metasulfobenzoate 0.076%w/v equivalent to dexamethasone 0.05% w/v Framycetin sulfate 0.67%w/v equivalent to framycetin 0.5% Gramicidin 0.005%w/v |
| Dosage Form: | Ear/eye drops |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | Zentiva ks, Prague, Czech Republic |
| Product: | Soframycin |
| Active Ingredient: | Framycetin sulfate 0.55%w/v |
| Dosage Form: | Ear/eye drops |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | Zentiva ks, Prague, Czech Republic |
| Product: | Vimpat |
| Active Ingredient: | Lacosamide 50mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Seqirus (NZ) Limited |
| Manufacturers: | UCB Pharma SA, Braine-l’Alleud, Belgium Aesica Pharmaceuticals GmbH, Zwickau, Germany |
| Product: | Vimpat |
| Active Ingredient: | Lacosamide 100mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Seqirus (NZ) Limited |
| Manufacturers: | UCB Pharma SA, Braine-l’Alleud, Belgium Aesica Pharmaceuticals GmbH, Zwickau, Germany |
| Product: | Vimpat |
| Active Ingredient: | Lacosamide 150mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Seqirus (NZ) Limited |
| Manufacturers: | UCB Pharma SA, Braine-l’Alleud, Belgium Aesica Pharmaceuticals GmbH, Zwickau, Germany |
| Product: | Vimpat |
| Active Ingredient: | Lacosamide 200mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Seqirus (NZ) Limited |
| Manufacturers: | UCB Pharma SA, Braine-l’Alleud, Belgium Aesica Pharmaceuticals GmbH, Zwickau, Germany |
Dated this 15th day of January 2024.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).