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: | Biktarvy |
| Active Ingredients: | Bictegravir sodium 52.45mg equivalent to bictegravir 50mg Emtricitabine 200mg Tenofovir alafenamide fumarate 28.04mg equivalent to tenofovir alafenamide 25mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Gilead Sciences (NZ) |
| Manufacturers: | Rottendorf Pharma GmbH, Ennigerloh, Germany Gilead Sciences Ireland UC, Carrigtohill, Ireland |
| Product: | Diarrhoea Relief |
| Active Ingredient: | Loperamide hydrochloride 2mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Medreich New Zealand Limited |
| Manufacturer: | Adcock Ingram Limited - A Medreich Group Company, Bangalore, India |
| Product: | Erythromycin Panpharma |
| Active Ingredient: | Erythromycin lactobionate 1.49g equivalent to erythromycin 1g |
| Dosage Form: | Powder for infusion |
| New Zealand Sponsor: | Multichem NZ Limited |
| Manufacturer: | Panpharma-Beignon, Beignon, France |
| Product: | Lynparza |
| Active Ingredient: | Olaparib 100mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | AstraZeneca Limited |
| Manufacturer: | AbbVie Deutschland GmbH & Co KG, Ludwigshafen, Germany |
| Product: | Lynparza |
| Active Ingredient: | Olaparib 150mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | AstraZeneca Limited |
| Manufacturer: | AbbVie Deutschland GmbH & Co KG, Ludwigshafen, Germany |
| Product: | Medreich Loperamide (General sale) |
| Active Ingredient: | Loperamide hydrochloride 2mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Medreich New Zealand Limited |
| Manufacturer: | Adcock Ingram Limited - A Medreich Group Company, Bangalore, India |
| Product: | Medreich Loperamide (Pharmacy only) |
| Active Ingredient: | Loperamide hydrochloride 2mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Medreich New Zealand Limited |
| Manufacturer: | Adcock Ingram Limited - A Medreich Group Company, Bangalore, India |
| Product: | Paracetamol+ Ibuprofen |
| Active Ingredients: | Paracetamol 500mgIbuprofen 200mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | PSM Healthcare Limited trading as API Consumer Brands |
| Manufacturer: | Medreich Limited, Bangalore, India |
| Product: | Ritemvia (100mg/10mL) |
| Active Ingredient: | Rituximab 10mg/mL |
| Dosage Form: | Concentrate for infusion |
| New Zealand Sponsor: | Celltrion Healthcare New Zealand Limited |
| Manufacturer: | Celltrion Inc., Incheon, South Korea |
| Product: | Ritemvia (500mg/50mL) |
| Active Ingredient: | Rituximab 10mg/mL |
| Dosage Form: | Concentrate for infusion |
| New Zealand Sponsor: | Celltrion Healthcare New Zealand Limited |
| Manufacturer: | Celltrion Inc., Incheon, South Korea |
| Product: | Tobramycin BNM |
| Active Ingredient: | Tobramycin 300mg |
| Dosage Form: | Solution for inhalation |
| New Zealand Sponsor: | Boucher & Muir (New Zealand) Limited t/a BNM Group |
| Manufacturers: | Holopack Verpackungstechnik GmbH, Abstgmund-Untergroningen, Germany Holopack Verpackungstechnik GmbH, Sulzback-Laufen, Germany |
| Product: | Tobramycin Wockhardt |
| Active Ingredient: | Tobramycin 300mg |
| Dosage Form: | Solution for inhalation |
| New Zealand Sponsor: | InterPharma (NZ) Limited |
| Manufacturers: | Holopack Verpackungstechnik GmbH, Abstgmund-Untergroningen, Germany Holopack Verpackungstechnik GmbH, Sulzback-Laufe, Germany |
| Product: | Truxima (100mg/10mL) |
| Active Ingredient: | Rituximab 10mg/mL |
| Dosage Form: | Concentrate for infusion |
| New Zealand Sponsor: | Celltrion Healthcare New Zealand Limited |
| Manufacturer: | Celltrion Inc., Incheon, South Korea |
| Product: | Truxima (500mg/50mL) |
| Active Ingredient: | Rituximab 10mg/mL |
| Dosage Form: | Concentrate for infusion |
| New Zealand Sponsor: | Celltrion Healthcare New Zealand Limited |
| Manufacturer: | Celltrion Inc., Incheon, South Korea |
| Product: | Voltaren Emulgel No Mess Applicator |
| Active Ingredient: | Diclofenac diethylamine 1.16%w/w equivalent to diclofenac 1%w/w |
| Dosage Form: | Topical gel |
| New Zealand Sponsor: | GlaxoSmithKline Consumer Healthcare New Zealand Limited |
| Manufacturers: | GSK Consumer Healthcare SA, Nyon, Switzerland Novartis Pharma Produktions GmbH, Wehr, Germany Purna Pharmaceuticals NV, Puurs, Belgium |
Dated this 9th day of August 2019.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).