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 which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:
Schedule
| Product: | Drixine No Drip Formula - Menthol Aroma Pump Mist Nasal Spray |
| Active Ingredient: | Oxymetazoline hydrochloride 0.5mg/mL |
| Dosage Form: | Nasal spray solution |
| New Zealand Sponsor: | Bayer New Zealand Limited |
| Manufacturers: | CPL Contract Pharmaceuticals Limited, Mississauga, Canada Famar Montreal Inc, Point Claire, Canada |
| Product: | Drixine No Drip Formula - Moisturising Pump Mist Nasal Spray |
| Active Ingredient: | Oxymetazoline hydrochloride 0.5mg/mL |
| Dosage Form: | Nasal spray solution |
| New Zealand Sponsor: | Bayer New Zealand Limited |
| Manufacturers: | CPL Contract Pharmaceuticals Limited, Mississauga, Canada Famar Montreal Inc, Point Claire, Canada |
| Product: | Drixine No Drip Formula Original Pump Mist Nasal Spray |
| Active Ingredient: | Oxymetazoline hydrochloride 0.5mg/mL |
| Dosage Form: | Nasal spray solution |
| New Zealand Sponsor: | Bayer New Zealand Limited |
| Manufacturers: | CPL Contract Pharmaceuticals Limited, Mississauga, Canada Famar Montreal Inc, Point Claire, Canada |
| Product: | Herceptin |
| Active Ingredient: | Trastuzumab 150mg |
| Dosage Form: | Powder for infusion concentrate |
| New Zealand Sponsor: | Roche Products (NZ) Limited |
| Manufacturers: | F Hoffmann-La Roche Limited, Basel, Switzerland Roche Diagnostics GmbH, Mannheim, Germany Genentech Inc, Oregon, United States of America |
| Product: | Herceptin |
| Active Ingredient: | Trastuzumab 440mg |
| Dosage Form: | Powder for infusion concentrate with diluent |
| New Zealand Sponsor: | Roche Products (NZ) Limited |
| Manufacturers: | Genentech Inc, California, United States of America F Hoffmann-La Roche Limited, Basel, Switzerland Genentech Inc, Oregon, United States of America |
| Product: | Herclon |
| Active Ingredient: | Trastuzumab 150mg |
| Dosage Form: | Powder for infusion concentrate |
| New Zealand Sponsor: | Roche Products (NZ) Limited |
| Manufacturers: | Roche Diagnostics GmbH, Mannheim, Germany F Hoffmann-La Roche Limited, Basel, Switzerland Genentech Inc, Oregon, United States of America |
| Product: | Herclon |
| Active Ingredient: | Trastuzumab 440mg |
| Dosage Form: | Powder for infusion concentrate with diluent |
| New Zealand Sponsor: | Roche Products (NZ) Limited |
| Manufacturers: | F Hoffmann-La Roche Limited, Basel, Switzerland Genentech Inc, California, United States of America Genentech Inc, Oregon, United States of America |
| Product: | NovoEight |
| Active Ingredient: | Turoctocog alfa 250IU |
| Dosage Form: | Powder for injection with diluent |
| New Zealand Sponsor: | Novo Nordisk Pharmaceuticals Limited |
| Manufacturer: | Novo Nordisk A/S, Gentofte, Denmark |
| Product: | NovoEight |
| Active Ingredient: | Turoctocog alfa 500IU |
| Dosage Form: | Powder for injection with diluent |
| New Zealand Sponsor: | Novo Nordisk Pharmaceuticals Limited |
| Manufacturer: | Novo Nordisk A/S, Gentofte, Denmark |
| Product: | NovoEight |
| Active Ingredient: | Turoctocog alfa 1000IU |
| Dosage Form: | Powder for injection with diluent |
| New Zealand Sponsor: | Novo Nordisk Pharmaceuticals Limited |
| Manufacturer: | Novo Nordisk A/S, Gentofte, Denmark |
| Product: | NovoEight |
| Active Ingredient: | Turoctocog alfa 1500IU |
| Dosage Form: | Powder for injection with diluent |
| New Zealand Sponsor: | Novo Nordisk Pharmaceuticals Limited |
| Manufacturer: | Novo Nordisk A/S, Gentofte, Denmark |
| Product: | NovoEight |
| Active Ingredient: | Turoctocog alfa 2000IU |
| Dosage Form: | Powder for injection with diluent |
| New Zealand Sponsor: | Novo Nordisk Pharmaceuticals Limited |
| Manufacturer: | Novo Nordisk A/S, Gentofte, Denmark |
| Product: | NovoEight |
| Active Ingredient: | Turoctocog alfa 3000IU |
| Dosage Form: | Powder for injection with diluent |
| New Zealand Sponsor: | Novo Nordisk Pharmaceuticals Limited |
| Manufacturer: | Novo Nordisk A/S, Gentofte, Denmark |
| Product: | Valganciclovir |
| Active Ingredient: | Valganciclovir hydrochloride 496.286mg equivalent to valganciclovir 450mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Max Health Limited |
| Manufacturer: | Oman Pharmaceutical Products Company LLC, Salalah, Oman |
| Product: | Zobacin |
| Active Ingredients: | Piperacillin 2g equivalent to piperacillin sodium 2.085g Tazobactam 250mg equivalent to tazobactam sodium 268.3mg |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | Mylan New Zealand Limited |
| Manufacturers: | Laboratorio Farmaceutico CT SrL, Imperia, Italy Mitim SrL, Brescia, Italy |
| Product: | Zobacin |
| Active Ingredients: | Piperacillin 4g equivalent to piperacillin sodium 4.17g Tazobactam 500mg equivalent to tazobactam sodium 536.6mg |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | Mylan New Zealand Limited |
| Manufacturers: | Laboratorio Farmaceutico CT SrL, Imperia, Italy Mitim SrL, Brescia, Italy |
Dated this 5th day of October 2020.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).