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: | Bonjela Mouth Ulcer Gel |
| Active Ingredient: | Choline salicylate 8.714%w/w (formed in process from choline bicarbonate and salicylic acid) |
| Dosage Form: | Oral topical gel |
| New Zealand Sponsor: | Reckitt Benckiser (New Zealand) Limited |
| Manufacturer: | Reckitt Benckiser Healthcare (UK) Limited, Hull, United Kingdom |
| Product: | Jakavi |
| Active Ingredient: | Ruxolitinib phosphate 6.6mg equivalent to ruxolitinib 5mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Novartis Pharma Stein AG, Stein, Switzerland |
| Product: | Jakavi |
| Active Ingredient: | Ruxolitinib phosphate 13.2mg equivalent to ruxolitinib 10mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Novartis Pharma Stein AG, Stein, Switzerland |
| Product: | Jakavi |
| Active Ingredient: | Ruxolitinib phosphate 19.8mg equivalent to ruxolitinib 15mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Novartis Pharma Stein AG, Stein, Switzerland |
| Product: | Jakavi |
| Active Ingredient: | Ruxolitinib phosphate 26.4mg equivalent to ruxolitinib 20mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Novartis Pharma Stein AG, Stein, Switzerland |
| Product: | Vimpat |
| Active Ingredient: | Lacosamide 10mg/mL |
| Dosage Form: | Oral solution |
| New Zealand Sponsor: | Seqirus (NZ) Limited |
| Manufacturer: | Unither Manufacturing LLC, New York, United States of America |
| 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, Monza, Italy |
Dated this 29th day of July 2022.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).