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: | Apomine Intermittent |
| Active Ingredient: | Apomorphine hydrochloride hemihydrate 30mg |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturer: | Recipharm Monts SAS, Monts, France |
| Product: | CandaDerm |
| Active Ingredients: | Clotrimazole 1%w/w Hydrocortisone 1%w/w |
| Dosage Form: | Topical cream |
| New Zealand Sponsor: | AFT Pharmaceuticals Limited |
| Manufacturer: | Hoe Pharmaceuticals Sdn Bhd, Port Klang, Malaysia |
| Product: | DP-Posaconazole |
| Active Ingredient: | Posaconazole 40mg/mL |
| Dosage Form: | Oral suspension |
| New Zealand Sponsor: | Douglas Pharmaceuticals Limited |
| Manufacturer: | Douglas Manufacturing Limited, Auckland, New Zealand |
| Product: | Medix Anaesthetic Lozenges (Sugar Free Berry) |
| Active Ingredients: | Benzydamine hydrochloride 3mg Dichlorobenzyl alcohol 1.2mg Lidocaine hydrochloride monohydrate 4mg |
| Dosage Form: | Lozenge |
| New Zealand Sponsor: | Nova Pharmaceuticals NZ Limited |
| Manufacturer: | Makson Health Care (Private) Limited, Mandideep, India |
| Product: | Medix Anaesthetic Lozenges (Sugar Free Blackcurrant) |
| Active Ingredients: | Benzydamine hydrochloride 3mg Dichlorobenzyl alcohol 1.2mg Lidocaine hydrochloride monohydrate 4mg |
| Dosage Form: | Lozenge |
| New Zealand Sponsor: | Nova Pharmaceuticals NZ Limited |
| Manufacturer: | Makson Health Care (Private) Limited, Mandideep, India |
| Product: | Medix Anaesthetic Lozenges (Sugar Free Honey & Lemon) |
| Active Ingredients: | Benzydamine hydrochloride 3mg Dichlorobenzyl alcohol 1.2mg Lidocaine hydrochloride monohydrate 4mg |
| Dosage Form: | Lozenge |
| New Zealand Sponsor: | Nova Pharmaceuticals NZ Limited |
| Manufacturer: | Makson Health Care (Private) Limited, Mandideep, India |
| Product: | Medix Anaesthetic Lozenges (Sugar Free Menthol) |
| Active Ingredients: | Benzydamine hydrochloride 3mg Dichlorobenzyl alcohol 1.2mg Lidocaine hydrochloride monohydrate 4mg |
| Dosage Form: | Lozenge |
| New Zealand Sponsor: | Nova Pharmaceuticals NZ Limited |
| Manufacturer: | Makson Health Care (Private) Limited, Manideep, India |
| Product: | Morphine Sulfate (Medicianz) |
| Active Ingredient: | Morphine sulfate pentahydrate 2mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Medicianz Healthcare Limited |
| Manufacturer: | HBM Pharma s.r.o., Martin, Slovakia |
| Product: | Morphine Sulfate (Medsurge) |
| Active Ingredient: | Morphine sulfate pentahydrate 2mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Medicianz Healthcare Limited |
| Manufacturer: | HBM Pharma s.r.o., Martin, Slovakia |
| Product: | Morphine Sulfate (Medicianz) |
| Active Ingredient: | Morphine sulfate pentahydrate 5mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Medicianz Healthcare Limited |
| Manufacturer: | HBM Pharma s.r.o., Martin, Slovakia |
| Product: | Morphine Sulfate (Medsurge) |
| Active Ingredient: | Morphine sulfate pentahydrate 5mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Medicianz Healthcare Limited |
| Manufacturer: | HBM Pharma s.r.o., Martin, Slovakia |
| Product: | Morphine Sulfate (Medicianz) |
| Active Ingredient: | Morphine sulfate pentahydrate 10mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Medicianz Healthcare Limited |
| Manufacturer: | HBM Pharma s.r.o., Martin, Slovakia |
| Product: | Morphine Sulfate (Medsurge) |
| Active Ingredient: | Morphine sulfate pentahydrate 10mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Medicianz Healthcare Limited |
| Manufacturer: | HBM Pharma s.r.o., Martin, Slovakia |
| Product: | Morphine Sulfate (Medicianz) |
| Active Ingredient: | Morphine sulfate pentahydrate 15mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Medicianz Healthcare Limited |
| Manufacturer: | HBM Pharma s.r.o., Martin, Slovakia |
| Product: | Morphine Sulfate (Medsurge) |
| Active Ingredient: | Morphine sulfate pentahydrate 15mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Medicianz Healthcare Limited |
| Manufacturer: | HBM Pharma s.r.o., Martin, Slovakia |
| Product: | Morphine Sulfate (Medicianz) |
| Active Ingredient: | Morphine sulfate pentahydrate 30mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Medicianz Healthcare Limited |
| Manufacturer: | HBM Pharma s.r.o., Martin, Slovakia |
| Product: | Morphine Sulfate (Medsurge) |
| Active Ingredient: | Morphine sulfate pentahydrate 30mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Medicianz Healthcare Limited |
| Manufacturer: | HBM Pharma s.r.o., Martin, Slovakia |
| Product: | Pacimol |
| Active Ingredient: | Paracetamol 500mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Ipca Pharma (NZ) Pty Limited |
| Manufacturer: | Ipca Laboratories Limited, Silvassa, India |
| Product: | Paracetamol |
| Active Ingredient: | Paracetamol 500mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Ipca Pharma (NZ) Pty Limited |
| Manufacturer: | Ipca Laboratories Limited, Silvassa, India |
| Product: | Xarelto |
| Active Ingredient: | Rivaroxaban 2.5mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Bayer New Zealand Limited |
| Manufacturers: | Bayer AG, Leverkusen, Germany Bayer Healthcare Manufacturing Srl, Milano, Italy |
Dated this 5th day of October 2020.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).