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: | Afstyla |
| Active Ingredient: | Lonoctocog alfa 250IU |
| Dosage Form: | Powder for injection with diluent |
| New Zealand Sponsor: | CSL Behring (NZ) Limited |
| Manufacturer: | CSL Behring GmbH, Marburg, Germany |
| Product: | Afstyla |
| Active Ingredient: | Lonoctocog alfa 500IU |
| Dosage Form: | Powder for injection with diluent |
| New Zealand Sponsor: | CSL Behring (NZ) Limited |
| Manufacturer: | CSL Behring GmbH, Marburg, Germany |
| Product: | Afstyla |
| Active Ingredient: | Lonoctocog alfa 1000IU |
| Dosage Form: | Powder for injection with diluent |
| New Zealand Sponsor: | CSL Behring (NZ) Limited |
| Manufacturer: | CSL Behring GmbH, Marburg, Germany |
| Product: | Afstyla |
| Active Ingredient: | Lonoctocog alfa 1500IU |
| Dosage Form: | Powder for injection with diluent |
| New Zealand Sponsor: | CSL Behring (NZ) Limited |
| Manufacturer: | CSL Behring GmbH, Marburg, Germany |
| Product: | Afstyla |
| Active Ingredient: | Lonoctocog alfa 2000IU |
| Dosage Form: | Powder for injection with diluent |
| New Zealand Sponsor: | CSL Behring (NZ) Limited |
| Manufacturer: | CSL Behring GmbH, Marburg, Germany |
| Product: | Afstyla |
| Active Ingredient: | Lonoctocog alfa 2500IU |
| Dosage Form: | Powder for injection with diluent |
| New Zealand Sponsor: | CSL Behring (NZ) Limited |
| Manufacturer: | CSL Behring GmbH, Marburg, Germany |
| Product: | Afstyla |
| Active Ingredient: | Lonoctocog alfa 3000IU |
| Dosage Form: | Powder for injection with diluent |
| New Zealand Sponsor: | CSL Behring (NZ) Limited |
| Manufacturer: | CSL Behring GmbH, Marburg, Germany |
| Product: | Marcain with adrenaline |
| Active Ingredients: | Adrenaline acid tartrate 1:200000 Bupivacaine hydrochloride monohydrate 0.5% |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | Recipharm Monts SAS, Monts, France |
| Product: | Marcain with adrenaline |
| Active Ingredients: | Adrenaline acid tartrate 1:400000 Bupivacaine hydrochloride monohydrate 0.25% |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | Recipharm Monts SAS, Monts, France |
| Product: | Pheburane |
| Active Ingredient: | Sodium phenylbutyrate 84g |
| Dosage Form: | Oral granules |
| New Zealand Sponsor: | Orpharma NZ Limited |
| Manufacturer: | Rottendorf Pharma GmbH, Ennigerloh, Germany |
Dated this 23rd day of November 2023.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).