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: | Orkambi (Tablet) |
| Active Ingredients: | Ivacaftor 125mg Lumacaftor 100mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturers: | Aesica Queenborough Limited, Kent, United Kingdom Pharmaceutical Manufacturing Research Services Inc, Pennsylvania, United States of America |
| Product: | Orkambi (Tablet) |
| Active Ingredients: | Ivacaftor 125mg Lumacaftor 200mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturers: | Vertex Pharmaceutical Incorporated, Massachusetts, United States of America Aesica Queenborough Limited, Kent, United Kingdom Pharmaceutical Manufacturing Research Services Inc, Pennsylvania, United States of America |
| Product: | Orkambi (Granules) |
| Active Ingredients: | Ivacaftor 125mg Lumacaftor 100mg |
| Dosage Form: | Oral granules |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | Aesica Queenborough Limited, Kent, United Kingdom |
| Product: | Orkambi (Granules) |
| Active Ingredients: | Ivacaftor 188mg Lumacaftor 150mg |
| Dosage Form: | Oral granules |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | Aesica Queenborough Limited, Kent, United Kingdom |
Dated this 28th day of February 2023.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).