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: | Albunate 5 |
| Active Ingredient: | Albumin 50g/L |
| Dosage Form: | Solution for infusion |
| New Zealand Sponsor: | CSL Behring (NZ) Limited |
| Manufacturers: | CSL Behring AG, Bern, Switzerland CSL Behring LLC, Illinois, United States of America |
| Product: | Albunate 20 |
| Active Ingredient: | Albumin 200g/L |
| Dosage Form: | Solution for infusion |
| New Zealand Sponsor: | CSL Behring (NZ) Limited |
| Manufacturers: | CSL Behring AG, Bern, Switzerland CSL Behring LLC, Illinois, United States of America |
| Product: | Albunate 25 |
| Active Ingredient: | Albumin 250g/L |
| Dosage Form: | Solution for infusion |
| New Zealand Sponsor: | CSL Behring (NZ) Limited |
| Manufacturers: | CSL Behring AG, Bern, Switzerland CSL Behring LLC, Illinois, United States of America |
| Product: | Diclofenac 25 |
| Active Ingredient: | Diclofenac sodium 25mg |
| Dosage Form: | Enteric coated tablet |
| New Zealand Sponsor: | Medreich New Zealand Limited |
| Manufacturer: | Medreich Limited, Bangalore, India |
| Product: | Imfinzi |
| Active Ingredient: | Durvalumab 120mg |
| Dosage Form: | Concentrate for infusion |
| New Zealand Sponsor: | AstraZeneca Limited |
| Manufacturer: | Catalent Indiana LLC, Indiana, United States of America |
| Product: | Imfinzi |
| Active Ingredient: | Durvalumab 500mg |
| Dosage Form: | Concentrate for infusion |
| New Zealand Sponsor: | AstraZeneca Limited |
| Manufacturer: | Catalent Indiana LLC, Indiana, United States of America |
| Product: | Maxigesic IV |
| Active Ingredients: | Ibuprofen sodium dihydrate 3.85mg/mL equivalent to ibuprofen 3mg/mL Paracetamol 10mg/mL |
| Dosage Form: | Solution for infusion |
| New Zealand Sponsor: | AFT Pharmaceuticals Limited |
| Manufacturer: | S.M. Farmaceutici SRL, Tito, Italy |
| Product: | Medreich Diclofenac 25 |
| Active Ingredient: | Diclofenac sodium 25mg |
| Dosage Form: | Enteric coated tablet |
| New Zealand Sponsor: | Medreich New Zealand Limited |
| Manufacturer: | Medreich Limited, Bangalore, India |
| Product: | Modafinil |
| Active Ingredient: | Modafinil 100mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Max Health Limited |
| Manufacturer: | Chanelle Medical Limited, Loughrea, Ireland |
| Product: | Parecoxib |
| Active Ingredient: | Parecoxib sodium 42.36mg equivalent to parecoxib 40mg |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | Neo Health (NZ) Limited |
| Manufacturer: | Anfarm Hellas SA, Schimatari, Greece |
| Product: | Parecoxib |
| Active Ingredient: | Parecoxib sodium 42.36mg equivalent to parecoxib 40mg |
| Dosage Form: | Powder for injection with diluent |
| New Zealand Sponsor: | Neo Health (NZ) Limited |
| Manufacturer: | Anfarm Hellas SA, Schimatari, Greece |
| Product: | Precedex Ready To Use (80mcg/20mL) |
| Active Ingredient: | Dexmedetomidine hydrochloride 4.72mcg/mL equivalent to dexmedetomidine 4mcg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturer: | Hospira Inc, Kansas, United States of America |
| Product: | Precedex Ready To Use (200mcg/50mL) |
| Active Ingredient: | Dexmedetomidine hydrochloride 4.72mcg/mL equivalent to dexmedetomidine 4mcg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturer: | Hospira Inc, Kansas, United States of America |
| Product: | Precedex Ready To Use (400mcg/100mL) |
| Active Ingredient: | Dexmedetomidine hydrochloride 4.72mcg/mL equivalent to dexmedetomidine 4mcg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturer: | Hospira Inc, Kansas, United States of America |
| Product: | Tecentriq |
| Active Ingredient: | Atezolizumab 840mg |
| Dosage Form: | Concentrate for infusion |
| New Zealand Sponsor: | Roche Products (NZ) Limited |
| Manufacturer: | F Hoffmann-La Roche Limited, Kaiseraugst, Switzerland |
Dated this 4th day of October 2019.
DEREK FITZGERALD, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).