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 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:
Schedule
| Product: | Keytruda |
| Active Ingredient: | Pembrolizumab 25mg/mL |
| Dosage Form: | Concentrate for infusion |
| New Zealand Sponsor: | Merck Sharp & Dohme (New Zealand) Limited |
| Manufacturer: | MSD International GmbH (Ireland), Carlow, Ireland |
| Product: | Keytruda |
| Active Ingredient: | Pembrolizumab 50mg |
| Dosage Form: | Powder for infusion |
| New Zealand Sponsor: | Merck Sharp & Dohme (New Zealand) Limited |
| Manufacturer: | MSD International GmbH, Innishannon, Ireland |
| Product: | Moviprep |
| Component 1: | |
| Active Ingredients: | Macrogol 3350 100g Potassium chloride 1.015g Sodium chloride 2.691g Sodium sulfate 7.5g |
| Dosage Form: | Powder for oral solution |
| Component 2: | |
| Active Ingredients: | Ascorbic acid 4.7g Sodium ascorbate 5.9g |
| Dosage Form: | Powder for oral solution |
| New Zealand Sponsor: | CARSL Consulting |
| Manufacturer: | Norgine (UK) Limited, Mid Glamorgan, United Kingdom |
| Product: | Moviprep Orange |
| Component 1: | |
| Active Ingredients: | Macrogol 3350 100g Potassium chloride 1.015g Sodium chloride 2.691g Sodium sulfate 7.5g |
| Dosage Form: | Powder for oral solution |
| Component 2: | |
| Active Ingredients: | Ascorbic acid 4.7g Sodium ascorbate 5.9g |
| Dosage Form: | Powder for oral solution |
| New Zealand Sponsor: | CARSL Consulting |
| Manufacturer: | Norgine (UK) Limited, Mid Glamorgan, United Kingdom |
| Product: | Nucala |
| Active Ingredient: | Mepolizumab 144mg |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | GlaxoSmithKline (NZ) Limited |
| Manufacturer: | GlaxoSmithKline Manufacturing SpA, Parma, Italy |
| Product: | Tecentriq |
| Active Ingredient: | Atezolizumab 1200mg |
| Dosage Form: | Concentrate for infusion |
| New Zealand Sponsor: | Roche Products (NZ) Limited |
| Manufacturers: | Roche Diagnostics GmbH, Mannheim, Germany F Hoffmann-La Roche Limited, Kaiseraugst, Switzerland |
Dated this 25th day of November 2019.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).