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: | Glenmark Adapalene |
| Active Ingredient: | Adapalene 0.1%w/w |
| Dosage Form: | Topical gel |
| New Zealand Sponsor: | Pharmaco (NZ) Limited |
| Manufacturer: | Glenmark Pharmaceuticals Limited, Goa, India |
| Product: | TAKHZYRO |
| Active Ingredient: | Lanadelumab 150mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Shire New Zealand Limited |
| Manufacturer: | Catalent Indiana LLC, Indiana, United States of America |
| Product: | Trazimera |
| Active Ingredient: | Trastuzumab 150mg |
| Dosage Form: | Powder for infusion concentrate |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturer: | Pfizer Manufacturing Belgium NV, Puurs, Belgium |
| Product: | Trazimera |
| Active Ingredient: | Trastuzumab 440mg |
| Dosage Form: | Powder for infusion concentrate |
| Dosage Form: | Diluent |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturer: | Pfizer Manufacturing Belgium NV, Puurs, Belgium |
| Product: | UroFos |
| Active Ingredient: | Fosfomycin trometamol 5.631g equivalent to fosfomycin 3g |
| Dosage Form: | Oral granules |
| New Zealand Sponsor: | Te Arai BioFarma Limited |
| Manufacturer: | Labiana Pharmaceuticals S.L.U., Barcelona, Spain |
Dated this 15th 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).