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: | Esmolol hydrochloride Medicianz |
| Active Ingredient: | Esmolol hydrochloride 10mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Medsurge Pharma Limited |
| Manufacturer: | Caplin Steriles Limited, Gummidipoondi, India |
| Product: | Esmolol hydrochloride Medsurge |
| Active Ingredient: | Esmolol hydrochloride 10mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Medsurge Pharma Limited |
| Manufacturer: | Caplin Steriles Limited, Gummidipoondi, India |
| Product: | Ferric carboxymaltose Sandoz |
| Active Ingredient: | Ferric carboxymaltose 357mg equivalent to iron 100mg/2mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Sandoz New Zealand Limited |
| Manufacturer: | Lek Pharmaceuticals d.d., Ljubljana, Slovenia |
| Product: | Ferric carboxymaltose Sandoz |
| Active Ingredient: | Ferric carboxymaltose 1786mg equivalent to iron 500mg/10mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Sandoz New Zealand Limited |
| Manufacturer: | Lek Pharmaceuticals d.d., Ljubljana, Slovenia |
| Product: | Ferric carboxymaltose Sandoz |
| Active Ingredient: | Ferric carboxymaltose 3571mg equivalent to iron 1000mg/20mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Sandoz New Zealand Limited |
| Manufacturer: | Lek Pharmaceuticals d.d., Ljubljana, Slovenia |
| Product: | Metronidamed |
| Active Ingredient: | Metronidazole 200mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Medsurge Pharma Limited |
| Manufacturer: | GPAX Pharmaceuticals Private Limited, Daman, India |
| Product: | Metronidamed |
| Active Ingredient: | Metronidazole 400mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Medsurge Pharma Limited |
| Manufacturer: | GPAX Pharmaceuticals Private Limited, Daman, India |
| Product: | Metronidazole (Medicianz) |
| Active Ingredient: | Metronidazole 200mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Medsurge Pharma Limited |
| Manufacturer: | GPAX Pharmaceuticals Private Limited, Daman, India |
| Product: | Metronidazole (Medsurge) |
| Active Ingredient: | Metronidazole 200mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Medsurge Pharma Limited |
| Manufacturer: | GPAX Pharmaceuticals Private Limited, Daman, India |
| Product: | Metronidazole (Medicianz) |
| Active Ingredient: | Metronidazole 400mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Medsurge Pharma Limited |
| Manufacturer: | GPAX Pharmaceuticals Private Limited, Daman, India |
| Product: | Metronidazole (Medsurge) |
| Active Ingredient: | Metronidazole 400mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Medsurge Pharma Limited |
| Manufacturer: | GPAX Pharmaceuticals Private Limited, Daman, India |
| Product: | Plerixafor |
| Active Ingredient: | Plerixafor 20mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Teva Pharma (New Zealand) Limited |
| Manufacturer: | PLIVA Croatia Limited, Zagreb, Croatia |
| Product: | Sarclisa (100mg/5mL) |
| Active Ingredient: | Isatuximab 20mg/mL |
| Dosage Form: | Concentrate for injection |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany |
| Product: | Sarclisa (500mg/25mL) |
| Active Ingredient: | Isatuximab 20mg/mL |
| Dosage Form: | Concentrate for injection |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany |
| Product: | Xembify (1g/5mL) |
| Active Ingredient: | Normal immunoglobulin 180mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Pharmaco (NZ) Limited |
| Manufacturer: | Grifols Therapeutics LLC, North Carolina, United States of America |
| Product: | Xembify (2g/10mL) |
| Active Ingredient: | Normal immunoglobulin 180mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Pharmaco (NZ) Limited |
| Manufacturer: | Grifols Therapeutics LLC, North Carolina, United States of America |
| Product: | Xembify (4g/20mL) |
| Active Ingredient: | Normal immunoglobulin 180mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Pharmaco (NZ) Limited |
| Manufacturer: | Grifols Therapeutics LLC, North Carolina, United States of America |
| Product: | Xembify (10g/50mL) |
| Active Ingredient: | Normal immunoglobulin 180mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Pharmaco (NZ) Limited |
| Manufacturer: | Grifols Therapeutics LLC, North Carolina, United States of America |
Dated this 20th 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).