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: | AdiraMedica Docusate Sodium & Senna Tablets |
| Active Ingredients: | Docusate sodium 50mg Sennoside A+B calcium 40mg equivalent to Sennosides B 8mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | AdiraMedica Pty Limited |
| Manufacturer: | Sunglow Lifescience Private Limited, Uthiramerur Taluk, India |
| Product: | Jemperli |
| Active Ingredient: | Dostarlimab 50mg/mL |
| Dosage Form: | Solution for infusion |
| New Zealand Sponsor: | GlaxoSmithKline NZ Limited |
| Manufacturers: | Glaxo Operations UK Limited t/a Glaxo Wellcome Operations, Barnard Castle, United Kingdom Ajinomoto Althea Inc, California, United States of America |
| Product: | Omlyclo (75mg/0.5mL) |
| Active Ingredient: | Omalizumab 150mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Celltrion Healthcare New Zealand Limited |
| Manufacturer: | Celltrion Pharm Inc, Cheongju-si, South Korea |
| Product: | Omlyclo (150mg/1mL) |
| Active Ingredient: | Omalizumab 150mg |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Celltrion Healthcare New Zealand Limited |
| Manufacturer: | Celltrion Pharm Inc, Cheongju-si, South Korea |
| Product: | Terlipressin Acetate AFT |
| Active Ingredient: | Terlipressin acetate 0.12mg/mL equivalent to terlipressin 0.1mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | AFT Pharmaceuticals Limited |
| Manufacturer: | Hainan Poly Pharma Co. Limited, Haikou, China |
Dated this 1st day of April 2025.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).