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: | Inflectra |
| Active Ingredient: | Infliximab 100mg |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturers: | Gensenta llac Sanayii ve Ticaret A.S., Instanbul, Turkey Celltrion Inc., Incheon, South Korea |
| Product: | Lynparza |
| Active Ingredient: | Olaparib 100mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | AstraZeneca Limited |
| Manufacturers: | AbbVie Deutschland GmbH & Co KG, Ludwigshafen, Germany AbbVie Limited, Barceloneta, Puerto Rico AstraZeneca AB, Sodertalje, Sweden |
| Product: | Lynparza |
| Active Ingredient: | Olaparib 150mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | AstraZeneca Limited |
| Manufacturers: | AbbVie Deutschland GmbH & Co KG, Ludwigshafen, Germany AbbVie Limited, Barceloneta, Puerto Rico AstraZeneca AB, Sodertalje, Sweden |
| Product: | Myozyme |
| Active Ingredient: | Alglucosidase alfa 52.5mg |
| Dosage Form: | Powder for infusion concentrate |
| New Zealand Sponsor: | Sanofi-Aventis New Zealand Limited |
| Manufacturer: | Genzyme Ireland Limited, Waterford, Ireland |
| Product: | Seretide |
| Active Ingredients: | Fluticasone propionate 8mg equivalent to 50mcg/dose Salmeterol xinafoate 5.8mg equivalent to salmeterol 25mcg/dose |
| Dosage Form: | Aerosol inhaler, metered dose |
| New Zealand Sponsor: | GlaxoSmithKline NZ Limited |
| Manufacturers: | Glaxo Wellcome Production, Evreux, France Glaxo Wellcome SA, Burgos, Spain |
| Product: | Seretide |
| Active Ingredients: | Fluticasone propionate 20mg equivalent to 125mcg/dose Salmeterol xinafoate 5.8mg equivalent to salmeterol 25mcg/dose |
| Dosage Form: | Aerosol inhaler, metered dose |
| New Zealand Sponsor: | GlaxoSmithKline NZ Limited |
| Manufacturers: | Glaxo Wellcome Production, Evreux, France Glaxo Wellcome SA, Burgos, Spain |
| Product: | Seretide |
| Active Ingredients: | Fluticasone propionate 40mg equivalent to 250mcg/dose Salmeterol xinafoate 5.8mg equivalent to salmeterol 25mcg/dose |
| Dosage Form: | Aerosol inhaler, metered dose |
| New Zealand Sponsor: | GlaxoSmithKline NZ Limited |
| Manufacturers: | Glaxo Wellcome Production, Evreux, France Glaxo Wellcome SA, Burgos, Spain |
| Product: | Seretide Accuhaler |
| Active Ingredients: | Fluticasone propionate 100mcg Salmeterol xinafoate 72.5mcg equivalent to 50mcg of salmeterol base |
| Dosage Form: | Powder for inhalation |
| New Zealand Sponsor: | GlaxoSmithKline NZ Limited |
| Manufacturers: | Glaxo Operations UK Limited t/a Glaxo Welcome Operations, Hertfordshire, United Kingdom Glaxo Wellcome Production, Evreux, France GlaxoSmithKline LLC, North Carolina, United States of America |
| Product: | Seretide Accuhaler |
| Active Ingredients: | Fluticasone propionate 250mcg Salmeterol xinafoate 72.5mcg equivalent to 50mcg of salmeterol base |
| Dosage Form: | Powder for inhalation |
| New Zealand Sponsor: | GlaxoSmithKline NZ Limited |
| Manufacturers: | Glaxo Operations UK Limited t/a Glaxo Welcome Operations, Hertfordshire, United Kingdom Glaxo Wellcome Production, Evreux, France GlaxoSmithKline LLC, North Carolina, United States of America |
| Product: | Trajentamet |
| Active Ingredients: | Linagliptin 2.5mg Metformin hydrochloride 500mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Boehringer Ingelheim (NZ) Limited |
| Manufacturers: | Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany Dragenopharm, Apotheker Puschl GmbH & Co. KG, Tittmoning, Germany |
| Product: | Trajentamet |
| Active Ingredients: | Linagliptin 2.5mg Metformin hydrochloride 850mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Boehringer Ingelheim (NZ) Limited |
| Manufacturers: | Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany Dragenopharm, Apotheker Puschl GmbH & Co. KG, Tittmoning, Germany |
| Product: | Trajentamet |
| Active Ingredients: | Linagliptin 2.5mg Metformin hydrochloride 1000mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Boehringer Ingelheim (NZ) Limited |
| Manufacturers: | Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany Dragenopharm, Apotheker Puschl GmbH & Co. KG, Tittmoning, Germany |
| Product: | ViruPOS |
| Active Ingredient: | Aciclovir 30mg/g |
| Dosage Form: | Eye ointment |
| New Zealand Sponsor: | AFT Pharmaceuticals Limited |
| Manufacturer: | Ursapharm Arzneimittel GmbH, Saarbrucken, Germany |
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).