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: | Cetirizine Indoco |
| Active Ingredient: | Cetirizine hydrochloride 10mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Miro Healthcare Limited |
| Manufacturer: | Indoco Remedies Limited, Verna, India |
| Product: | Exemestane |
| Active Ingredient: | Exemestane 25mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Alchemy Health Limited |
| Manufacturer: | Remedica Limited, Limassol, Cyprus |
| Product: | Kalydeco |
| Active Ingredient: | Ivacaftor 25mg |
| Dosage Form: | Oral granules |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturers: | Almac Pharma Services Limited, Craigavon, United Kingdom Mayne Pharma Inc, North Carolina, United States of America Halo Pharmaceutical Inc, New Jersey, United States of America |
| Product: | Nicorette QuickMist SmartTrack |
| Active Ingredient: | Nicotine 13.6mg/mL |
| Dosage Form: | Oral spray |
| New Zealand Sponsor: | JNTL Consumer Health (New Zealand) Limited |
| Manufacturer: | McNeil AB, Helsingborg, Sweden |
| Product: | Privigen NZ (5g/50mL) |
| Active Ingredient: | Normal immunoglobulin 100mg/mL |
| Dosage Form: | Solution for infusion |
| New Zealand Sponsor: | CSL Behring (NZ) Limited |
| Manufacturer: | CSL Behring (Australia) Pty Limited, Melbourne, Australia |
| Product: | Privigen NZ (10g/100mL) |
| Active Ingredient: | Normal immunoglobulin 100mg/mL |
| Dosage Form: | Solution for infusion |
| New Zealand Sponsor: | CSL Behring (NZ) Limited |
| Manufacturer: | CSL Behring (Australia) Pty Limited, Melbourne, Australia |
| Product: | Privigen NZ (20g/200mL) |
| Active Ingredient: | Normal immunoglobulin 100mg/mL |
| Dosage Form: | Solution for infusion |
| New Zealand Sponsor: | CSL Behring (NZ) Limited |
| Manufacturer: | CSL Behring (Australia) Pty Limited, Melbourne, Australia |
| Product: | Privigen NZ (40g/400mL) |
| Active Ingredient: | Normal immunoglobulin 100mg/mL |
| Dosage Form: | Solution for infusion |
| New Zealand Sponsor: | CSL Behring (NZ) Limited |
| Manufacturer: | CSL Behring (Australia) Pty Limited, Melbourne, Australia |
Dated this 8th day of March 2023.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).