Consent to the Distribution of New Medicines
Pursuant 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:
| Product: | Alprolix |
| Active Ingredient: | Eftrenonacog alfa 4000IU |
| Dosage Form: | Powder for infusion with diluent |
| New Zealand Sponsor: | Sanofi-Aventis New Zealand Limited |
| Manufacturer: | Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany |
| Product: | Calquence |
| Active Ingredient: | Acalabrutinib 100mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | AstraZeneca Limited |
| Manufacturer: | AstraZeneca AB, Sodertalje, Sweden |
| Product: | Copaxone Pen |
| Active Ingredient: | Glatiramer acetate 40mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Teva Pharma (New Zealand) Limited |
| Manufacturers: | IVAX Pharmaceuticals UK Limited, Runcorn Cheshire, United Kingdom Teva Pharmaceutical Industries Limited, Kfar Saba, Israel |
| Product: | DBL™ Bortezomib |
| Active Ingredient: | Bortezomib 1mg |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturer: | Gland Pharma Limited, Visakhapatnam, India |
| Product: | Dexmedetomidine Ever Pharma (200mcg/2mL) |
| Active Ingredient: | Dexmedetomidine hydrochloride 0.1182mg/mL equivalent to dexmedetomidine 0.1mg/mL |
| Dosage Form: | Concentrate for injection |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | EVER Pharma Jena GmbH, Jena, Germany |
| Product: | Dexmedetomidine Ever Pharma (400mcg/4mL) |
| Active Ingredient: | Dexmedetomidine hydrochloride 0.1182mg/mL equivalent to dexmedetomidine 0.1mg/mL |
| Dosage Form: | Concentrate for injection |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | EVER Pharma Jena GmbH, Jena, Germany |
| Product: | Dexmedetomidine Ever Pharma (1000mcg/10mL) |
| Active Ingredient: | Dexmedetomidine hydrochloride 0.1182mg/mL equivalent to dexmedetomidine 0.1mg/mL |
| Dosage Form: | Concentrate for injection |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | EVER Pharma Jena GmbH, Jena, Germany |
| Product: | Docetaxel Accord (20mg/mL) |
| Active Ingredient: | Docetaxel 20mg/mL |
| Dosage Form: | Concentrate for injection |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | Intas Pharmaceuticals Limited, Ahmedabad, India |
| Product: | Docetaxel Accord (80mg/4mL) |
| Active Ingredient: | Docetaxel 20mg/mL |
| Dosage Form: | Concentrate for injection |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | Intas Pharmaceuticals Limited, Ahmedabad, India |
| Product: | Docetaxel Accord (160mg/8mL) |
| Active Ingredient: | Docetaxel 20mg/mL |
| Dosage Form: | Concentrate for injection |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | Intas Pharmaceuticals Limited, Ahmedabad, India |
| Product: | Erlotinib |
| Active Ingredient: | Erlotinib hydrochloride 27.317mg equivalent to erlotinib 25mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Multichem NZ Limited |
| Manufacturer: | Cipla Limited, Verna, India |
| Product: | Erlotinib |
| Active Ingredient: | Erlotinib hydrochloride 109.267mg equivalent to erlotinib 100mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Multichem NZ Limited |
| Manufacturer: | Cipla Limited, Verna, India |
| Product: | Erlotinib |
| Active Ingredient: | Erlotinib hydrochloride 163.9mg equivalent to erlotinib 150mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Multichem NZ Limited |
| Manufacturer: | Cipla Limited, Verna, India |
| Product: | Gefitinib |
| Active Ingredient: | Gefitinib 250mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Multichem NZ Limited |
| Manufacturer: | Cipla Limited, Verna, India |
| Product: | Hospira™ Bortezomib |
| Active Ingredient: | Bortezomib 1mg |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturer: | Gland Pharma Limited, Visakhapatnam, India |
| Product: | Levetiracetam Mylan |
| Active Ingredient: | Levetiracetam 250mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Viatris Limited |
| Manufacturer: | Intas Pharmaceuticals Limited, Ahmedabad, India |
| Product: | Levetiracetam Mylan |
| Active Ingredient: | Levetiracetam 500mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Viatris Limited |
| Manufacturer: | Intas Pharmaceuticals Limited, Ahmedabad, India |
| Product: | Levetiracetam Mylan |
| Active Ingredient: | Levetiracetam 750mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Viatris Limited |
| Manufacturer: | Intas Pharmaceuticals Limited, Ahmedabad, India |
| Product: | Levetiracetam Mylan |
| Active Ingredient: | Levetiracetam 1000mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Viatris Limited |
| Manufacturer: | Intas Pharmaceuticals Limited, Ahmedabad, India |
| Product: | Movapo Pen |
| Active Ingredient: | Apomorphine hydrochloride hemihydrate 10mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | CARSL Consulting |
| Manufacturer: | CP Pharmaceuticals Limited, Wrexham, United Kingdom |
| Product: | Ondansetron-AFT (4mg/2mL) |
| Active Ingredient: | Ondansetron hydrochloride dihydrate 2.49mg/mL equivalent to ondansetron 2mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | AFT Pharmaceuticals Limited |
| Manufacturer: | Qilu Pharmaceutical Co Limited, Jinan, China |
| Product: | Ondansetron-AFT (8mg/4mL) |
| Active Ingredient: | Ondansetron hydrochloride dihydrate 2.49mg/mL equivalent to ondansetron 2mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | AFT Pharmaceuticals Limited |
| Manufacturer: | Qilu Pharmaceutical Co Limited, Jinan, China |
| Product: | Sugammadex BNM (200mg/2mL) |
| Active Ingredient: | Sugammadex sodium 108.8mg/mL equivalent to sugammadex 100mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Boucher & Muir (New Zealand) Limited t/a BNM Group |
| Manufacturers: | PharmIdea, Olaine, Latvia Mefar Ilac Sanayii A.S., Istanbul, Turkey |
| Product: | Sugammadex BNM (500mg/5mL) |
| Active Ingredient: | Sugammadex sodium 108.8mg/mL equivalent to sugammadex 100mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Boucher & Muir (New Zealand) Limited t/a BNM Group |
| Manufacturers: | PharmIdea, Olaine, Latvia Mefar Ilac Sanayii A.S., Istanbul, Turkey |
| Product: | Sunitinib Pfizer |
| Active Ingredient: | Sunitinib malate 16.7mg equivalent to sunitinib 12.5mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturer: | Pfizer Italia SrL, Ascoli Piceno, Italy |
| Product: | Sunitinib Pfizer |
| Active Ingredient: | Sunitinib malate 33.4mg equivalent to sunitinib 25mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturer: | Pfizer Italia SrL, Ascoli Piceno, Italy |
| Product: | Sunitinib Pfizer |
| Active Ingredient: | Sunitinib malate 50.1mg equivalent to sunitinib 37.5mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturer: | Pfizer Italia SrL, Ascoli Piceno, Italy |
| Product: | Sunitinib Pfizer |
| Active Ingredient: | Sunitinib malate 66.8mg equivalent to sunitinib 50mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturer: | Pfizer Italia SrL, Ascoli Piceno, Italy |
| Product: | Trulicity |
| Active Ingredient: | Dulaglutide 3mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Eli Lilly and Company (NZ) Limited |
| Manufacturers: | Eli Lilly and Co Inc, Indiana, United States of America Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany |
| Product: | Ucedane |
| Active Ingredient: | Carglumic acid 200mg |
| Dosage Form: | Dispersible tablet |
| New Zealand Sponsor: | Orpharma NZ Limited |
| Manufacturer: | Unither Developpement Bordeaux, Le Haillan, France |
Dated this 9th day of August 2021.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).