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: | ATRACURIUM BESILATE (25mg/2.5mL) (Medicianz) |
| Active Ingredient: | Atracurium besilate 10mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Medsurge Pharma Limited |
| Manufacturer: | HBM Pharma s.r.o., Martin, Slovakia |
| Product: | ATRACURIUM BESILATE (25mg/2.5mL) (Medsurge) |
| Active Ingredient: | Atracurium besilate 10mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Medsurge Pharma Limited |
| Manufacturer: | HBM Pharma s.r.o., Martin, Slovakia |
| Product: | ATRACURIUM BESILATE (50mg/5mL) (Medicianz) |
| Active Ingredient: | Atracurium besilate 10mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Medsurge Pharma Limited |
| Manufacturer: | HBM Pharma s.r.o., Martin, Slovakia |
| Product: | ATRACURIUM BESILATE (50mg/5mL) (Medsurge) |
| Active Ingredient: | Atracurium besilate 10mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Medsurge Pharma Limited |
| Manufacturer: | HBM Pharma s.r.o., Martin, Slovakia |
| Product: | Dexamethasone (4mg/1mL) (Medicianz) |
| Active Ingredient: | Dexamethasone sodium phosphate 4.37mg/mL equivalent to dexamethasone phosphate 4mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Medsurge Pharma Limited |
| Manufacturer: | HBM Pharma s.r.o., Martin, Slovakia |
| Product: | Dexamethasone (4mg/1mL) (Medsurge) |
| Active Ingredient: | Dexamethasone sodium phosphate 4.37mg/mL equivalent to dexamethasone phosphate 4mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Medsurge Pharma Limited |
| Manufacturer: | HBM Pharma s.r.o., Martin, Slovakia |
| Product: | Dexamethasone (8mg/2mL) (Medicianz) |
| Active Ingredient: | Dexamethasone sodium phosphate 4.37mg/mL equivalent to dexamethasone phosphate 4mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Medsurge Pharma Limited |
| Manufacturer: | HBM Pharma s.r.o., Martin, Slovakia |
| Product: | Dexamethasone (8mg/2mL) (Medsurge) |
| Active Ingredient: | Dexamethasone sodium phosphate 4.37mg/mL equivalent to dexamethasone phosphate 4mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Medsurge Pharma Limited |
| Manufacturer: | HBM Pharma s.r.o., Martin, Slovakia |
| Product: | Enoxaparin Sodium (20mg/0.2mL) |
| Active Ingredient: | Enoxaparin sodium 100mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Multichem NZ Limited |
| Manufacturer: | Nanjing King-Friend Biochemical Pharmaceutical Co. Limited, Nanjing, China |
| Product: | Enoxaparin Sodium (40mg/0.4mL) |
| Active Ingredient: | Enoxaparin sodium 100mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Multichem NZ Limited |
| Manufacturer: | Nanjing King-Friend Biochemical Pharmaceutical Co. Limited, Nanjing, China |
| Product: | Enoxaparin Sodium (60mg/0.6mL) |
| Active Ingredient: | Enoxaparin sodium 100mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Multichem NZ Limited |
| Manufacturer: | Nanjing King-Friend Biochemical Pharmaceutical Co. Limited, Nanjing, China |
| Product: | Enoxaparin Sodium (80mg/0.8mL) |
| Active Ingredient: | Enoxaparin sodium 100mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Multichem NZ Limited |
| Manufacturer: | Nanjing King-Friend Biochemical Pharmaceutical Co. Limited, Nanjing, China |
| Product: | Enoxaparin Sodium (100mg/1mL) |
| Active Ingredient: | Enoxaparin sodium 100mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Multichem NZ Limited |
| Manufacturer: | Nanjing King-Friend Biochemical Pharmaceutical Co. Limited, Nanjing, China |
| Product: | FENTANYL (100mcg/2mL) (Medicianz) |
| Active Ingredient: | Fentanyl citrate 78.5mcg/mL equivalent to fentanyl 50mcg/ml |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Medsurge Pharma Limited |
| Manufacturer: | HBM Pharma s.r.o., Martin, Slovakia |
| Product: | FENTANYL (100mcg/2mL) (Medsurge) |
| Active Ingredient: | Fentanyl citrate 78.5mcg/mL equivalent to fentanyl 50mcg/ml |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Medsurge Pharma Limited |
| Manufacturer: | HBM Pharma s.r.o., Martin, Slovakia |
| Product: | FENTANYL (500mcg/10mL) (Medicianz) |
| Active Ingredient: | Fentanyl citrate 78.5mcg/mL equivalent to fentanyl 50mcg/ml |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Medsurge Pharma Limited |
| Manufacturer: | HBM Pharma s.r.o., Martin, Slovakia |
| Product: | FENTANYL (500mcg/10mL) (Medsurge) |
| Active Ingredient: | Fentanyl citrate 78.5mcg/mL equivalent to fentanyl 50mcg/ml |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Medsurge Pharma Limited |
| Manufacturer: | HBM Pharma s.r.o., Martin, Slovakia |
| Product: | Tyruko |
| Active Ingredient: | Natalizumab 20mg/mL |
| Dosage Form: | Solution for infusion |
| New Zealand Sponsor: | Sandoz New Zealand Limited |
| Manufacturer: | Patheon Italia S.p.A, Ferentino, Italy |
Dated this 12th day of July 2024.
DEREK FITZGERALD, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).