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: | Dasatinib APOTEX |
| Active Ingredient: | Dasatinib 20mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Apotex NZ Limited |
| Manufacturer: | Apotex Inc, Toronto, Canada |
| Product: | Dasatinib APOTEX |
| Active Ingredient: | Dasatinib 50mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Apotex NZ Limited |
| Manufacturer: | Apotex Inc, Toronto, Canada |
| Product: | Dasatinib APOTEX |
| Active Ingredient: | Dasatinib 70mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Apotex NZ Limited |
| Manufacturer: | Apotex Inc, Toronto, Canada |
| Product: | Dasatinib APOTEX |
| Active Ingredient: | Dasatinib 100mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Apotex NZ Limited |
| Manufacturer: | Apotex Inc, Toronto, Canada |
| Product: | Rekovelle |
| Active Ingredient: | Follitropin delta 12mcg |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Pharmaco (NZ) Limited |
| Manufacturers: | Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany Ferring Controlled Therapeutics Limited, East Kilbride, United Kingdom |
| Product: | Rekovelle |
| Active Ingredient: | Follitropin delta 36mcg |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Pharmaco (NZ) Limited |
| Manufacturers: | Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany Ferring Controlled Therapeutics Limited, East Kilbride, United Kingdom |
| Product: | Rekovelle |
| Active Ingredient: | Follitropin delta 72mcg |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Pharmaco (NZ) Limited |
| Manufacturers: | Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany Ferring Controlled Therapeutics Limited, East Kilbride, United Kingdom |
Dated this 27th day of January 2020.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).