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 Ibuprofen Suspension |
| Active Ingredient: | Ibuprofen 20mg/mL |
| Dosage Form: | Oral suspension |
| New Zealand Sponsor: | AdiraMedica Pty Limited. |
| Manufacturer: | Gracure Pharmaceuticals Limited, Bhiwadi, India |
| Product: | Adiramedica Ibuprofen Suspension Double Strength |
| Active Ingredient: | Ibuprofen 40mg/mL |
| Dosage Form: | Oral suspension |
| New Zealand Sponsor: | AdiraMedica Pty Limited. |
| Manufacturer: | Gracure Pharmaceuticals Limited, Bhiwadi, India |
| Product: | Budesonide MR BNM |
| Active Ingredient: | Budesonide 3mg |
| Dosage Form: | Modified release capsule |
| New Zealand Sponsor: | Boucher & Muir (New Zealand) Limited t/a BNM Group |
| Manufacturer: | Laboratorios Liconsa SA, Guadalajara, Spain |
| Product: | Galafold |
| Active Ingredient: | Migalastat 123mg equivalent to migalastat hydrochloride 150mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | Almac Pharma Services Limited, Craigavon, United Kingdom |
| Product: | Gastro-Soothe |
| Active Ingredient: | Hyoscine butylbromide 20mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | AFT Pharmaceuticals Limited |
| Manufacturer: | YSP Industries (M) Sdn. Bhd., Kajang, Malaysia |
| Product: | Nicorandil |
| Active Ingredient: | Nicorandil 10mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Max Health Limited |
| Manufacturer: | Rivopharm SA, Manno, Switzerland |
| Product: | Nicorandil |
| Active Ingredient: | Nicorandil 20mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Max Health Limited |
| Manufacturer: | Rivopharm SA, Manno, Switzerland |
| Product: | Noradrenaline (1mg/mL) (Medicianz) |
| Active Ingredient: | Noradrenaline acid tartrate monohydrate 2mg/mL equivalent to noradrenaline 1mg/mL |
| Dosage Form: | Concentrate for injection |
| New Zealand Sponsor: | Medicianz Healthcare Limited |
| Manufacturer: | HBM Pharma s.r.o., Martin, Slovakia |
| Product: | Noradrenaline (2mg/2mL) (Medicianz) |
| Active Ingredient: | Noradrenaline acid tartrate monohydrate 2mg/mL equivalent to noradrenaline 1mg/mL |
| Dosage Form: | Concentrate for injection |
| New Zealand Sponsor: | Medicianz Healthcare Limited |
| Manufacturer: | HBM Pharma s.r.o., Martin, Slovakia |
| Product: | Noradrenaline (4mg/4mL) (Medicianz) |
| Active Ingredient: | Noradrenaline acid tartrate monohydrate 2mg/mL equivalent to noradrenaline 1mg/mL |
| Dosage Form: | Concentrate for injection |
| New Zealand Sponsor: | Medicianz Healthcare Limited |
| Manufacturer: | HBM Pharma s.r.o., Martin, Slovakia |
| Product: | Noradrenaline (5mg/5mL) (Medicianz) |
| Active Ingredient: | Noradrenaline acid tartrate monohydrate 2mg/mL equivalent to noradrenaline 1mg/mL |
| Dosage Form: | Concentrate for injection |
| New Zealand Sponsor: | Medicianz Healthcare Limited |
| Manufacturer: | HBM Pharma s.r.o., Martin, Slovakia |
| Product: | Noradrenaline (8mg/8mL) (Medicianz) |
| Active Ingredient: | Noradrenaline acid tartrate monohydrate 2mg/mL equivalent to noradrenaline 1mg/mL |
| Dosage Form: | Concentrate for injection |
| New Zealand Sponsor: | Medicianz Healthcare Limited |
| Manufacturer: | HBM Pharma s.r.o., Martin, Slovakia |
| Product: | Noradrenaline (10mg/10mL) (Medicianz) |
| Active Ingredient: | Noradrenaline acid tartrate monohydrate 2mg/mL equivalent to noradrenaline 1mg/mL |
| Dosage Form: | Concentrate for injection |
| New Zealand Sponsor: | Medicianz Healthcare Limited |
| Manufacturer: | HBM Pharma s.r.o., Martin, Slovakia |
| Product: | Noradrenaline (1mg/mL) (Medicianz) |
| Active Ingredient: | Noradrenaline acid tartrate monohydrate 2mg/mL equivalent to noradrenaline 1mg/mL |
| Dosage Form: | Concentrate for injection |
| New Zealand Sponsor: | Medicianz Healthcare Limited |
| Manufacturer: | HBM Pharma s.r.o., Martin, Slovakia |
| Product: | Noradrenaline (2mg/2mL) (Medsurge) |
| Active Ingredient: | Noradrenaline acid tartrate monohydrate 2mg/mL equivalent to noradrenaline 1mg/mL |
| Dosage Form: | Concentrate for injection |
| New Zealand Sponsor: | Medicianz Healthcare Limited |
| Manufacturer: | HBM Pharma s.r.o., Martin, Slovakia |
| Product: | Noradrenaline (4mg/4mL) (Medsurge) |
| Active Ingredient: | Noradrenaline acid tartrate monohydrate 2mg/mL equivalent to noradrenaline 1mg/mL |
| Dosage Form: | Concentrate for injection |
| New Zealand Sponsor: | Medicianz Healthcare Limited |
| Manufacturer: | HBM Pharma s.r.o., Martin, Slovakia |
| Product: | Noradrenaline (5mg/5mL) (Medsurge) |
| Active Ingredient: | Noradrenaline acid tartrate monohydrate 2mg/mL equivalent to noradrenaline 1mg/mL |
| Dosage Form: | Concentrate for injection |
| New Zealand Sponsor: | Medicianz Healthcare Limited |
| Manufacturer: | HBM Pharma s.r.o., Martin, Slovakia |
| Product: | Noradrenaline (8mg/8mL) (Medsurge) |
| Active Ingredient: | Noradrenaline acid tartrate monohydrate 2mg/mL equivalent to noradrenaline 1mg/mL |
| Dosage Form: | Concentrate for injection |
| New Zealand Sponsor: | Medicianz Healthcare Limited |
| Manufacturer: | HBM Pharma s.r.o., Martin, Slovakia |
| Product: | Noradrenaline (10mg/10mL) (Medsurge) |
| Active Ingredient: | Noradrenaline acid tartrate monohydrate 2mg/mL equivalent to noradrenaline 1mg/mL |
| Dosage Form: | Concentrate for injection |
| New Zealand Sponsor: | Medicianz Healthcare Limited |
| Manufacturer: | HBM Pharma s.r.o., Martin, Slovakia |
| Product: | Rocuronium Bromide (Medicianz) |
| Active Ingredient: | Rocuronium bromide 10mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Medicianz Healthcare Limited |
| Manufacturer: | Maiva Pharma Private Limited, Hosur, India |
| Product: | Rocuronium Bromide (Medsurge) |
| Active Ingredient: | Rocuronium bromide 10mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Medicianz Healthcare Limited |
| Manufacturer: | Maiva Pharma Private Limited, Hosur, India |
| Product: | Vabysmo |
| Active Ingredient: | Faricimab 120mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Roche Products (NZ) Limited |
| Manufacturer: | F. Hoffmann-La Roche AG, Kaiseraugst, Switzerland |
Dated this 2nd day of October 2023.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).