Consent to the Distribution of New Medicines
Pursuant 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:
| Product: | Acetazolamide (Medicianz) |
| Active Ingredient: | Acetazolamide 250mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Medicianz Healthcare Limited |
| Manufacturer: | Celogen Generics Pvt Limited, Daman, India |
| Product: | Acetazolamide (Medsurge) |
| Active Ingredient: | Acetazolamide 250mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Medicianz Healthcare Limited |
| Manufacturer: | Celogen Generics Pvt Limited, Daman, India |
| Product: | Atectura |
| Active Ingredients: | Indacaterol acetate 173mcg equivalent to indacaterol 150mcg Mometasone furoate 80mcg |
| Dosage Form: | Powder filled inhalation capsule |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Novartis Pharma Stein AG, Stein, Switzerland |
| Product: | Atectura |
| Active Ingredients: | Indacaterol acetate 173mcg equivalent to indacaterol 150mcg Mometasone furoate 160mcg |
| Dosage Form: | Powder filled inhalation capsule |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Novartis Pharma Stein AG, Stein, Switzerland |
| Product: | Atectura |
| Active Ingredients: | Indacaterol acetate 173mcg equivalent to indacaterol 150mcg Mometasone furoate 320mcg |
| Dosage Form: | Powder filled inhalation capsule |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Novartis Pharma Stein AG, Stein, Switzerland |
| Product: | DP-Captopril |
| Active Ingredient: | Captopril 5mg/mL |
| Dosage Form: | Oral solution |
| New Zealand Sponsor: | Douglas Pharmaceuticals Limited |
| Manufacturer: | Syri Limited, Ruislip, United Kingdom |
| Product: | DP-Febuxostat |
| Active Ingredient: | Febuxostat 80mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Douglas Pharmaceuticals Limited |
| Manufacturer: | Indoco Remedies Limited, Verna, India |
| Product: | DP-Febuxostat |
| Active Ingredient: | Febuxostat 120mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Douglas Pharmaceuticals Limited |
| Manufacturer: | Indoco Remedies Limited, Verna, India |
| Product: | Entyvio |
| Active Ingredient: | Vedolizumab 300mg |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | Takeda New Zealand Limited |
| Manufacturers: | Patheon Italia SpA, Frosinone, Italy Takeda Pharmaceutical Company Limited, Yamaguchi, Japan |
| Product: | Gabapentin (Medicianz) |
| Active Ingredient: | Gabapentin 100mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Medicianz Healthcare Limited |
| Manufacturer: | Micro Labs Limited, Verna, India |
| Product: | Gabapentin (Medsurge) |
| Active Ingredient: | Gabapentin 100mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Medicianz Healthcare Limited |
| Manufacturer: | Micro Labs Limited, Verna, India |
| Product: | Gabapentin (Medicianz) |
| Active Ingredient: | Gabapentin 300mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Medicianz Healthcare Limited |
| Manufacturer: | Micro Labs Limited, Verna, India |
| Product: | Gabapentin (Medsurge) |
| Active Ingredient: | Gabapentin 300mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Medicianz Healthcare Limited |
| Manufacturer: | Micro Labs Limited, Verna, India |
| Product: | Gabapentin (Medicianz) |
| Active Ingredient: | Gabapentin 400mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Medicianz Healthcare Limited |
| Manufacturer: | Micro Labs Limited, Verna, India |
| Product: | Gabapentin (Medsurge) |
| Active Ingredient: | Gabapentin 400mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Medicianz Healthcare Limited |
| Manufacturer: | Micro Labs Limited, Verna, India |
| Product: | Methadone – AFT |
| Active Ingredient: | Methadone hydrochloride 5mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | AFT Pharmaceuticals Limited |
| Manufacturer: | S.C. SANTA S.A., Brasov, Romania |
| Product: | Methadone – AFT |
| Active Ingredient: | Methadone hydrochloride 10mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | AFT Pharmaceuticals Limited |
| Manufacturer: | S.C. SANTA S.A., Brasov, Romania |
| Product: | Pelgraz |
| Active Ingredient: | Pegfilgrastim 10mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | Intas Pharmaceuticals Limited, Ahmedabad, India |
| Product: | Posaconazole Dr.Reddy’s |
| Active Ingredient: | Posaconazole 100mg |
| Dosage Form: | Modified release tablet |
| New Zealand Sponsor: | Dr Reddy’s New Zealand Limited |
| Manufacturer: | Dr Reddy’s Laboratories Limited, Srikakulam, India |
| Product: | Sugammadex Juno (200mg/2mL) |
| Active Ingredient: | Sugammadex sodium 108.8mg/mL equivalent to sugammadex 100mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Juno Pharmaceuticals NZ Limited |
| Manufacturer: | Lupin Limited, Nagpur, India |
| Product: | Sugammadex Juno (500mg/5mL) |
| Active Ingredient: | Sugammadex sodium 108.8mg/mL equivalent to sugammadex 100mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Juno Pharmaceuticals NZ Limited |
| Manufacturer: | Lupin Limited, Nagpur, India |
Dated this 29th day of August 2022.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).