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: | Nucala (Pre-Filled Pen) |
| Active Ingredient: | Mepolizumab 100mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | GlaxoSmithKline (NZ) Limited |
| Manufacturer: | Glaxo Operations UK Limited t/a Glaxo Welcome Operations, Barnard Castle, United Kingdom |
| Product: | Nucala (Pre-Filled Syringe) |
| Active Ingredient: | Mepolizumab 100mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | GlaxoSmithKline (NZ) Limited |
| Manufacturer: | Glaxo Operations UK Limited t/a Glaxo Welcome Operations, Barnard Castle, United Kingdom |
| Product: | Paxtine |
| Active Ingredient: | Paroxetine hydrochloride 22.22mg equivalent to paroxetine 20mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Mylan New Zealand Limited |
| Manufacturer: | Alphapharm Pty Limited, Brisbane, Australia |
| Product: | Pemetrexed-AFT |
| Active Ingredient: | Pemetrexed disodium hemipentahydrate 120.82mg equivalent to pemetrexed 100mg |
| Dosage Form: | Powder for infusion |
| New Zealand Sponsor: | AFT Pharmaceuticals Limited |
| Manufacturer: | Qilu Pharmaceutical (Hainan) Co Limited, Haikou, China |
| Product: | Pemetrexed-AFT |
| Active Ingredient: | Pemetrexed disodium hemipentahydrate 604.12mg equivalent to pemetrexed 500mg |
| Dosage Form: | Powder for infusion |
| New Zealand Sponsor: | AFT Pharmaceuticals Limited |
| Manufacturer: | Qilu Pharmaceutical (Hainan) Co Limited, Haikou, China |
Dated this 9th day of February 2021.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).