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: | Cetrotide |
| Active Ingredient: | Cetrorelix acetate 0.26mg equivalent to cetrorelix 0.25mg |
| Dosage Form: | Powder for injection |
| Dosage Form: | Diluent |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturers: | Simtra Deutschland GmbH, Westfalen, Germany Fareva Pau SAS, Idron, France |
| Product: | Diacomit |
| Active Ingredient: | Stiripentol 250mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Chiesi New Zealand Limited |
| Manufacturer: | Biocodex SAS, Beauvais, France |
| Product: | Diacomit |
| Active Ingredient: | Stiripentol 500mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Chiesi New Zealand Limited |
| Manufacturer: | Biocodex SAS, Beauvais, France |
| Product: | Diacomit |
| Active Ingredient: | Stiripentol 250mg |
| Dosage Form: | Powder for oral suspension |
| New Zealand Sponsor: | Chiesi New Zealand Limited |
| Manufacturer: | Biocodex SAS, Beauvais, France |
| Product: | Diacomit |
| Active Ingredient: | Stiripentol 500mg |
| Dosage Form: | Powder for oral suspension |
| New Zealand Sponsor: | Chiesi New Zealand Limited |
| Manufacturer: | Biocodex SAS, Beauvais, France |
| Product: | Glycoprep Orange |
| Active Ingredients: | Macrogol 3350 52.9g Potassium chloride 0.74g Sodium chloride 2.6g Sodium sulfate 5.6g |
| Dosage Form: | Powder for oral solution |
| New Zealand Sponsor: | Fresenius Kabi New Zealand Limited |
| Manufacturer: | Probiotec Pharma Pty Limited, Melbourne, Australia |
| Product: | Glycoprep-O Kit (Combination Product) |
| Component 1: | |
| Active Ingredient: | Bisacodyl 5mg |
| Dosage Form: | Bisacodyl Tablet |
| Component 2: | |
| Active Ingredients: | Citric acid 14.3g Magnesium carbonate monohydrate 7.2g |
| Dosage Form: | Magnesium citrate Powder for oral solution |
| Component 3: | |
| Active Ingredients: | Macrogol 3350 52.9g Potassium chloride 740mg Sodium chloride 2.6g Sodium sulfate 5.6g |
| Dosage Form: | Glycoprep Orange Oral powder |
| New Zealand Sponsor: | Fresenius Kabi New Zealand Limited |
| Manufacturers: | Probiotec Pharma Pty Limited, Melbourne, Australia Remedica Limited, Limassol Industrial Estate, Limassol, Cyprus |
| Product: | Picoprep Orange |
| Active Ingredients: | Citric acid 12.2g Magnesium carbonate monohydrate 7.4g Sodium picosulfate 10.3mg |
| Dosage Form: | Powder for oral solution |
| New Zealand Sponsor: | Fresenius Kabi New Zealand Limited |
| Manufacturer: | Probiotec Pharma Pty Limited, Melbourne, Australia |
| Product: | Prepkit Orange (Combination Product) |
| Component 1: | |
| Active Ingredients: | Macrogol 3350 52.9g Potassium chloride 740mg Sodium chloride 2.6g Sodium sulfate 5.6g |
| Dosage Form: | Component 1 Powder for oral solution |
| Component 2: | |
| Active Ingredients: | Citric acid 12.2g Magnesium carbonate monohydrate 7.4g Sodium picosulfate 10.3mg |
| Dosage Form: | Component 2 Powder for oral solution |
| New Zealand Sponsor: | Fresenius Kabi New Zealand Limited |
| Manufacturer: | Probiotec Pharma Pty Limited, Melbourne, Australia |
| Product: | Tevimbra |
| Active Ingredient: | Tislelizumab 10mg/mL |
| Dosage Form: | Concentrate for injection |
| New Zealand Sponsor: | BeOne Medicines NZ Unlimited |
| Manufacturer: | Boehringer Ingelheim Biopharmaceuticals (China) Limited., Shanghai, China |
| Note: | Application was received 30 June 2025. |
| Product: | Tevimbra |
| Active Ingredient: | Tislelizumab 10mg/mL |
| Dosage Form: | Concentrate for injection |
| New Zealand Sponsor: | BeOne Medicines NZ Unlimited |
| Manufacturer: | Boehringer Ingelheim Biopharmaceuticals (China) Limited., Shanghai, China |
| Note: | Application was received 31 October 2025. |
Dated this 21st day of April 2026.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).