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: | Azacitidine |
| Active Ingredient: | Azacitidine 100mg |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | REX Medical Limited |
| Manufacturer: | Cipla Limited, Goa, India |
| Product: | Beriplex P/N |
| Active Ingredients: | Factor II 200IU Factor IX 200IU Factor VII 100IU Factor X 220IU Protein C 150IU Protein S precursor 120IU Prothrombin complex concentrates 60mg |
| Dosage Form: | Powder for injection with diluent |
| New Zealand Sponsor: | CSL Behring (NZ) Limited |
| Manufacturer: | CSL Behring GmbH, Marburg, Germany |
| Product: | Beriplex P/N |
| Active Ingredients: | Factor II 400IU Factor IX 400IU Factor VII 200IU Factor X 440IU Protein C 300IU Protein S precursor 240IU Prothrombin complex concentrates 120mg |
| Dosage Form: | Powder for injection with diluent |
| New Zealand Sponsor: | CSL Behring (NZ) Limited |
| Manufacturer: | CSL Behring GmbH, Marburg, Germany |
| Product: | Beriplex P/N |
| Active Ingredients: | Factor II 800IU Factor IX 800IU Factor VII 400IU Factor X 880IU Protein C 600IU Protein S precursor 480IU Prothrombin complex concentrates 240mg |
| Dosage Form: | Powder for injection with diluent |
| New Zealand Sponsor: | CSL Behring (NZ) Limited |
| Manufacturer: | CSL Behring GmbH, Marburg, Germany |
| Product: | Braltus |
| Active Ingredient: | Tiotropium bromide monomethanolate 16.71mcg equivalent tiotropium 13mcg |
| Dosage Form: | Powder filled inhalation capsule |
| New Zealand Sponsor: | Teva Pharma (New Zealand) Limited |
| Manufacturer: | Laboratorios Liconsa SA, Guadalajara, Spain |
| Product: | Dexmedetomidine Sandoz |
| Active Ingredient: | Dexmedetomidine hydrochloride 118mcg/mL equivalent to dexmedetomidine 100mcg/mL |
| Dosage Form: | Concentrate for injection |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Jiangsu Hengrui Medicine Co Limited, Lianyungang, China |
| Product: | Ibuprofen 200 (General sale) |
| Active Ingredient: | Ibuprofen 200mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Medreich New Zealand Limited |
| Manufacturer: | Medreich Limited, Bangalore, India |
| Product: | Ibuprofen 200 (Pharmacy only) |
| Active Ingredient: | Ibuprofen 200mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Medreich New Zealand Limited |
| Manufacturer: | Medreich Limited, Bangalore, India |
| Product: | Medreich Ibuprofen (General sale) |
| Active Ingredient: | Ibuprofen 200mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Medreich New Zealand Limited |
| Manufacturer: | Medreich Limited, Bangalore, India |
| Product: | Medreich Ibuprofen (Pharmacy only) |
| Active Ingredient: | Ibuprofen 200mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Medreich New Zealand Limited |
| Manufacturer: | Medreich Limited, Bangalore, India |
| Product: | Ogivri |
| Active Ingredient: | Trastuzumab 150mg |
| Dosage Form: | Powder for infusion concentrate |
| New Zealand Sponsor: | Mylan New Zealand Limited |
| Manufacturer: | Biocon Limited, Bangalore, India |
| Product: | Ogivri |
| Active Ingredient: | Trastuzumab 440mg |
| Dosage Form: | Powder for infusion concentrate |
| New Zealand Sponsor: | Mylan New Zealand Limited |
| Manufacturer: | Biocon Limited, Bangalore, India |
| Product: | Rydapt |
| Active Ingredient: | Midostaurin 25mg |
| Dosage Form: | Soft gelatin capsule |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Catalent Germany Eberbach GmbH, Baden, Germany |
Dated this 21st day of October 2019.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).