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 set out in the Schedule hereto:
Schedule
| Product: | Diclofenac Anti-Inflammatory Pain Relief Gel |
| Active Ingredient: | Diclofenac sodium 10mg/g |
| Dosage Form: | Topical gel |
| New Zealand Sponsor: | PSM Healthcare Limited trading as API Consumer Brands |
| Manufacturer: | PSM Healthcare Limited trading as API Consumer Brands, Auckland, New Zealand |
| Product: | Monofer (100mg/mL) |
| Active Ingredient: | Ferric derisomaltose 417mg/mL equivalent to elemental iron 100mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturer: | Wasserburger Arzneimittelwerk GmbH, Wasserburg, Germany |
| Product: | Monofer (200mg/2mL) |
| Active Ingredient: | Ferric derisomaltose 417mg/mL equivalent to elemental iron 100mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturer: | Wasserburger Arzneimittelwerk GmbH, Wasserburg, Germany |
| Product: | Monofer (500mg/5mL) |
| Active Ingredient: | Ferric derisomaltose 417mg/mL equivalent to elemental iron 100mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturer: | Wasserburger Arzneimittelwerk GmbH, Wasserburg, Germany |
| Product: | Monofer (1000mg/10mL) |
| Active Ingredient: | Ferric derisomaltose 417mg/mL equivalent to elemental iron 100mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturer: | Wasserburger Arzneimittelwerk GmbH, Wasserburg, Germany |
| Product: | Optisulin |
| Active Ingredient: | Insulin glargine 100IU/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Sanofi-Aventis New Zealand Limited |
| Manufacturer: | Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany |
| Product: | Optisulin Solostar |
| Active Ingredient: | Insulin glargine 100IU/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Sanofi-Aventis New Zealand Limited |
| Manufacturer: | Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany |
| Product: | Rivaroxaban Sandoz |
| Active Ingredient: | Rivaroxaban 10mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Oman Pharmaceutical Products Company LLC, Salalah, Oman |
| Product: | Rivaroxaban Sandoz |
| Active Ingredient: | Rivaroxaban 15mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Oman Pharmaceutical Products Company LLC, Salalah, Oman |
| Product: | Rivaroxaban Sandoz |
| Active Ingredient: | Rivaroxaban 20mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Oman Pharmaceutical Products Company LLC, Salalah, Oman |
Dated this 21st day of August 2020.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).