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 which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:
| Product: | Demazin 12 Hour Nasal Decongestant Spray |
| Active Ingredient: | Oxymetazoline hydrochloride 0.5mg/mL |
| Dosage Form: | Nasal spray solution |
| New Zealand Sponsor: | Noumed Pharmaceuticals Limited |
| Manufacturer: | Probiotec Pharma Pty Limited, Melbourne, Australia |
| Product: | Demazin Cold + Flu Relief |
| Active Ingredients: | Paracetamol 500mg Phenylephrine hydrochloride 5mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Noumed Pharmaceuticals Limited |
| Manufacturer: | Probiotec Pharma Pty Limited, Melbourne, Australia |
| Product: | Lyrica |
| Active Ingredient: | Pregabalin 25mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturers: | Pfizer Manufacturing Deutschland GmbH, Freiburg Im Breisgau, Germany Pfizer Pharmaceuticals LLC, Vega Baja, Puerto Rico Strides Pharma Science Limited, Puducherry, India |
| Product: | Lyrica |
| Active Ingredient: | Pregabalin 75mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturers: | Pfizer Manufacturing Deutschland GmbH, Freiburg Im Breisgau, Germany Pfizer Pharmaceuticals LLC, Vega Baja, Puerto Rico Strides Pharma Science Limited, Puducherry, India |
| Product: | Lyrica |
| Active Ingredient: | Pregabalin 150mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturers: | Pfizer Manufacturing Deutschland GmbH, Freiburg Im Breisgau, Germany Pfizer Pharmaceuticals LLC, Vega Baja, Puerto Rico Strides Pharma Science Limited, Puducherry, India |
| Product: | Lyrica |
| Active Ingredient: | Pregabalin 300mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturers: | Pfizer Manufacturing Deutschland GmbH, Freiburg Im Breisgau, Germany Pfizer Pharmaceuticals LLC, Vega Baja, Puerto Rico Strides Pharma Science Limited, Puducherry, India |
| Product: | Trikafta 100/50/75 |
| Component 1: | |
| Active Ingredients: | Elexacaftor 100mg Ivacaftor 75mg Tezacaftor 50mg |
| Dosage Form: | Film coated tablet |
| Component 2: | |
| Active Ingredient: | Ivacaftor 150mg |
| 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 Patheon Pharmaceuticals Inc, Ohio, United States of America |
| Product: | Trikafta 50/25/37.5 |
| Component 1: | |
| Active Ingredients: | Elexacaftor 50mg Ivacaftor 37.5mg Tezacaftor 25mg |
| Dosage Form: | Film coated tablet |
| Component 2: | |
| Active Ingredient: | Ivacaftor 75mg |
| 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 Patheon Pharmaceuticals Inc, Ohio, United States of America |
Dated this 14th day of March 2025.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).