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: | Alecensa |
| Active Ingredient: | Alectinib hydrochloride 161.33mg equivalent to alectinib 150mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Roche Products (NZ) Limited |
| Manufacturer: | Excella GmbH & Co KG, Feucht, Germany |
| Product: | Enbrel |
| Active Ingredient: | Etanercept 25mg |
| Dosage Form: | Powder for injection with diluent |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturer: | Pfizer Manufacturing Belgium NV, Puurs, Belgium |
| Product: | Enbrel |
| Active Ingredient: | Etanercept 25mg |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturers: | Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany Pfizer Manufacturing Belgium NV, Puurs, Belgium |
| Note: This is for the application received 27 August 2019. | |
| Product: | Enbrel |
| Active Ingredient: | Etanercept 25mg |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturers: | Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany Pfizer Manufacturing Belgium NV, Puurs, Belgium |
| Note: This is for the application received 10 September 2019. | |
| Product: | Enbrel |
| Active Ingredient: | Etanercept 50mg |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturers: | Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany Pfizer Manufacturing Belgium NV, Puurs, Belgium Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany |
Dated this 2nd day of June 2020.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).