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: | Aprepitant |
| Component 1: | |
| Active Ingredient: | Aprepitant 80mg |
| Dosage Form: | Capsule |
| Component 2: | |
| Active Ingredient: | Aprepitant 125mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Max Health Limited |
| Manufacturer: | Ethypharm Industries, Grand Quevilly, France |
| Product: | Aquipta |
| Active Ingredient: | Atogepant monohydrate 10.3mg equivalent to atogepant 10mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | AbbVie Limited |
| Manufacturer: | Forest Laboratories Ireland Limited, Dublin, Ireland |
| Product: | Aquipta |
| Active Ingredient: | Atogepant monohydrate 61.8mg equivalent to atogepant 60mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | AbbVie Limited |
| Manufacturer: | Forest Laboratories Ireland Limited, Dublin, Ireland |
| Product: | Glycopyrronium-AFT |
| Active Ingredient: | Glycopyrronium bromide 0.2mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | AFT Pharmaceuticals Limited |
| Manufacturer: | Cadila Pharmaceuticals Limited, Dholka, India |
| Product: | Pfizer Daptomycin |
| Active Ingredient: | Daptomycin 350mg |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturer: | Hospira Australia Pty Limited, Melbourne, Australia |
| Product: | Pfizer Daptomycin |
| Active Ingredient: | Daptomycin 500mg |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturer: | Hospira Australia Pty Limited, Melbourne, Australia |
| Product: | Progesterone ADVZ |
| Active Ingredient: | Progesterone 100mg |
| Dosage Form: | Soft gelatin capsule |
| New Zealand Sponsor: | Boucher & Muir (New Zealand) Limited t/a BNM Group |
| Manufacturer: | Laboratorios Leon Farma S.A., Leon, Spain |
| Product: | Progesterone ADVZ |
| Active Ingredient: | Progesterone 200mg |
| Dosage Form: | Soft gelatin capsule |
| New Zealand Sponsor: | Boucher & Muir (New Zealand) Limited t/a BNM Group |
| Manufacturer: | Laboratorios Leon Farma S.A., Leon, Spain |
| Product: | Sensodyne Daily Care |
| Active Ingredients: | Potassium nitrate 50mg/g Sodium fluoride 3.152mg/g equivalent to fluoride 1426ppm |
| Dosage Form: | Oral paste |
| New Zealand Sponsor: | Haleon New Zealand ULC |
| Manufacturer: | Neocosmed Co Limited, Pathumthani, Thailand |
| Product: | Sensodyne Daily Care + Whitening |
| Active Ingredients: | Potassium nitrate 50mg/g Sodium fluoride 3.152mg/g equivalent to fluoride 1426ppm |
| Dosage Form: | Oral paste |
| New Zealand Sponsor: | Haleon New Zealand ULC |
| Manufacturer: | Neocosmed Co Limited, Pathumthani, Thailand |
| Product: | Sensodyne Deep Clean Daily Care |
| Active Ingredient: | Sodium fluoride 3.152mg/g equivalent to fluoride 1426ppm |
| Dosage Form: | Oral paste |
| New Zealand Sponsor: | Haleon New Zealand ULC |
| Manufacturer: | Neocosmed Co Limited, Pathumthani, Thailand |
| Product: | Teicoplanin (Medicianz) |
| Active Ingredient: | Teicoplanin 400mg |
| Dosage Form: | Powder for injection with diluent |
| New Zealand Sponsor: | Medsurge Pharma Limited |
| Manufacturer: | Aroma Ilac Sanayi Limited Sirketi, Tekirdag, Turkey |
| Product: | Teicoplanin (Medsurge) |
| Active Ingredient: | Teicoplanin 400mg |
| Dosage Form: | Powder for injection with diluent |
| New Zealand Sponsor: | Medsurge Pharma Limited |
| Manufacturer: | Aroma Ilac Sanayi Limited Sirketi, Tekirdag, Turkey |
| Product: | Yonsa Mpred |
| Component 1 | |
| Active Ingredient: | Abiraterone acetate 125mg |
| Dosage Form: | Tablet |
| Component 2: | |
| Active Ingredient: | Methylprednisolone 4mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | CARSL Consulting |
| Manufacturers: | Orion Corporation, Espoo, Finland Mayne Pharma Inc, North Carolina, United States of America |
Dated this 27th day of May 2024.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).