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: | Adiramedica Desloratadine |
| Active Ingredient: | Desloratadine 2.5mg/5mL |
| Dosage Form: | Syrup |
| New Zealand Sponsor: | AdiraMedica Pty Limited |
| Manufacturer: | Gracure Pharmaceuticals Limited, Bhiwadi, India |
| Product: | Cabometyx |
| Active Ingredient: | Cabozantinib s-malate 25.34mg equivalent to cabozantinib 20mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | Patheon Inc, Mississauga, Canada |
| Product: | Cabometyx |
| Active Ingredient: | Cabozantinib s-malate 50.69mg equivalent to cabozantinib 40mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | Patheon Inc, Mississauga, Canada |
| Product: | Cabometyx |
| Active Ingredient: | Cabozantinib s-malate 76.03mg equivalent to cabozantinib 60mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | Patheon Inc, Mississauga, Canada |
| Product: | Desloratadine Hayfever & Allergy Relief |
| Active Ingredient: | Desloratadine 2.5mg/5mL |
| Dosage Form: | Syrup |
| New Zealand Sponsor: | AdiraMedica Pty Limited |
| Manufacturer: | Gracure Pharmaceuticals Limited, Bhiwadi, India |
| Product: | Emgality (Prefilled Pen) |
| Active Ingredient: | Galcanezumab 120mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Eli Lilly and Company (NZ) Limited |
| Manufacturer: | Eli Lilly and Co Inc, Indiana, United States of America |
| Product: | Emgality (Prefilled Syringe) |
| Active Ingredient: | Galcanezumab 120mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Eli Lilly and Company (NZ) Limited |
| Manufacturer: | Eli Lilly and Co Inc, Indiana, United States of America |
| Product: | Fycompa |
| Active Ingredient: | Perampanel hemisesquihydrate 2.1mg equivalent to perampanel 2mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Eisai New Zealand Limited |
| Manufacturers: | Eisai Co Limited, Kakamigahara-shi, Japan Eisai Manufacturing Limited, Hatfield, United Kingdom |
| Product: | Fycompa |
| Active Ingredient: | Perampanel hemisesquihydrate 4.2mg equivalent to perampanel 4mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Eisai New Zealand Limited |
| Manufacturers: | Eisai Co Limited, Kakamigahara-shi, Japan Eisai Manufacturing Limited, Hatfield, United Kingdom |
| Product: | Fycompa |
| Active Ingredient: | Perampanel hemisesquihydrate 6.2mg equivalent to perampanel 6mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Eisai New Zealand Limited |
| Manufacturers: | Eisai Co Limited, Kakamigahara-shi, Japan Eisai Manufacturing Limited, Hatfield, United Kingdom |
| Product: | Fycompa |
| Active Ingredient: | Perampanel hemisesquihydrate 8.3mg equivalent to perampanel 8mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Eisai New Zealand Limited |
| Manufacturers: | Eisai Co Limited, Kakamigahara-shi, Japan Eisai Manufacturing Limited, Hatfield, United Kingdom |
| Product: | Fycompa |
| Active Ingredient: | Perampanel hemisesquihydrate 10.4mg equivalent to perampanel 10mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Eisai New Zealand Limited |
| Manufacturers: | Eisai Co Limited, Kakamigahara-shi, Japan Eisai Manufacturing Limited, Hatfield, United Kingdom |
| Product: | Fycompa |
| Active Ingredient: | Perampanel hemisesquihydrate 12.5mg equivalent to perampanel 12mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Eisai New Zealand Limited |
| Manufacturers: | Eisai Co Limited, Kakamigahara-shi, Japan Eisai Manufacturing Limited, Hatfield, United Kingdom |
| Product: | Paracetamol/Diphenhydramine |
| Active Ingredients: | Diphenhydramine hydrochloride 25mg Paracetamol 500mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Neo Health (NZ) Limited |
| Manufacturer: | Titan Laboratories Pvt Limited, Mahad, India |
Dated this 28th day of August 2020.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).