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: | 3% Citanest DENTAL with Octapressin |
| Active Ingredients: | Felypressin 0.54mcg/mL Prilocaine hydrochloride 3% |
| Dosage Form: | Suspension for injection |
| New Zealand Sponsor: | Dentsply Sirona (NZ) Limited |
| Manufacturers: | Pierrel S.p.A., Capua, Italy Laboratorios INIBSA S.A., Barcelona, Spain |
| Product: | Vimpat |
| Active Ingredient: | Lacosamide 50mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Seqirus (NZ) Limited |
| Manufacturer: | UCB Pharma SA, Braine-l’Alleud, Belgium |
| Product: | Vimpat |
| Active Ingredient: | Lacosamide 100mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Seqirus (NZ) Limited |
| Manufacturer: | UCB Pharma SA, Braine-l’Alleud, Belgium |
| Product: | Vimpat |
| Active Ingredient: | Lacosamide 150mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Seqirus (NZ) Limited |
| Manufacturer: | UCB Pharma SA, Braine-l’Alleud, Belgium |
| Product: | Vimpat |
| Active Ingredient: | Lacosamide 200mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Seqirus (NZ) Limited |
| Manufacturer: | UCB Pharma SA, Braine-l’Alleud, Belgium |
| Product: | Vimpat |
| Active Ingredient: | Lacosamide 10mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Seqirus (NZ) Limited |
| Manufacturers: | UCB Pharma SA, Braine-l’Alleud, Belgium Patheon Italia SpA, Milan, Italy |
Dated this 15th day of November 2019.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).