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: | Apo-Atomoxetine |
| Active Ingredient: | Atomoxetine hydrochloride 11.4mg equivalent to atomoxetine 10mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Arrotex Pharmaceuticals (NZ) Limited |
| Manufacturer: | Apotex Inc, Etobicoke, Canada |
| Product: | Apo-Atomoxetine |
| Active Ingredient: | Atomoxetine hydrochloride 20.5mg equivalent to atomoxetine 18mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Arrotex Pharmaceuticals (NZ) Limited |
| Manufacturer: | Apotex Inc, Etobicoke, Canada |
| Product: | Apo-Atomoxetine |
| Active Ingredient: | Atomoxetine hydrochloride 28.5mg equivalent to atomoxetine 25mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Arrotex Pharmaceuticals (NZ) Limited |
| Manufacturer: | Apotex Inc, Etobicoke, Canada |
| Product: | Apo-Atomoxetine |
| Active Ingredient: | Atomoxetine hydrochloride 45.5mg equivalent to atomoxetine 40mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Arrotex Pharmaceuticals (NZ) Limited |
| Manufacturer: | Apotex Inc, Etobicoke, Canada |
| Product: | Apo-Atomoxetine |
| Active Ingredient: | Atomoxetine hydrochloride 68.3mg equivalent to atomoxetine 60mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Arrotex Pharmaceuticals (NZ) Limited |
| Manufacturer: | Apotex Inc, Etobicoke, Canada |
| Product: | Apo-Atomoxetine |
| Active Ingredient: | Atomoxetine hydrochloride 91.2mg equivalent to atomoxetine 80mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Arrotex Pharmaceuticals (NZ) Limited |
| Manufacturer: | Apotex Inc, Etobicoke, Canada |
| Product: | Apo-Atomoxetine |
| Active Ingredient: | Atomoxetine hydrochloride 114mg equivalent to atomoxetine 100mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Arrotex Pharmaceuticals (NZ) Limited |
| Manufacturer: | Apotex Inc, Etobicoke, Canada |
| Product: | Difflam Plus Sore Throat Gargle & Mouth Solution Antiseptic + Anti-inflammatory |
| Active Ingredients: | Benzydamine hydrochloride 1.5mg/mL Chlorhexidine gluconate 1.2mg/mL |
| Dosage Form: | Mouthwash |
| New Zealand Sponsor: | iNova Pharmaceuticals (New Zealand) Limited |
| Manufacturer: | Ensign Laboratories Pty Limited, Melbourne, Australia |
| Product: | Myfortic |
| Active Ingredient: | Mycophenolate sodium 192.4mg equivalent to mycophenolic acid 180mg |
| Dosage Form: | Enteric coated tablet |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturers: | Novartis Pharma Stein AG, Stein, Switzerland Novartis Pharma Produktions GmbH, Wehr, Germany |
| Product: | Myfortic |
| Active Ingredient: | Mycophenolate sodium 384.8mg equivalent to mycophenolic acid 360mg |
| Dosage Form: | Enteric coated tablet |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturers: | Novartis Pharma Stein AG, Stein, Switzerland Novartis Pharma Produktions GmbH, Wehr, Germany |
| Product: | Riamet |
| Active Ingredients: | Artemether 20mg Lumefantrine 120mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Novartis Saglik ve Gida Urunleri Sanayi ve Ticaret AS, Istanbul, Turkey |
| Product: | Riamet Dispersible |
| Active Ingredients: | Artemether 20mg Lumefantrine 120mg |
| Dosage Form: | Dispersible tablet |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Novartis Saglik ve Gida Urunleri Sanayi ve Ticaret AS, Istanbul, Turkey |
| Product: | Sudafed Xylometazoline |
| Active Ingredient: | Xylometazoline hydrochloride 1mg/mL |
| Dosage Form: | Nasal spray solution |
| New Zealand Sponsor: | Johnson & Johnson (New Zealand) Limited |
| Manufacturer: | Famar Health Care Services Madrid SAU, Madrid, Spain |
| Product: | Symbicort Rapihaler 100/6 |
| Active Ingredients: | Budesonide 80mcg Formoterol fumarate 4.5mcg |
| Dosage Form: | Aerosol inhaler, metered dose |
| New Zealand Sponsor: | AstraZeneca Limited |
| Manufacturer: | AstraZeneca Dunkerque Production SCS, Dunkerque, France |
| Product: | Symbicort Rapihaler 200/6 |
| Active Ingredients: | Budesonide 160mcg Formoterol fumarate 4.5mcg |
| Dosage Form: | Aerosol inhaler, metered dose |
| New Zealand Sponsor: | AstraZeneca Limited |
| Manufacturer: | AstraZeneca Dunkerque Production SCS, Dunkerque, France |
Dated this 13th day of December 2021.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).