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: | Augmentin 125 |
| Active Ingredients: | Amoxicillin trihydrate 28.698mg/mL equivalent to amoxycillin 25mg/mL Potassium clavulanate 7.446mg/mL equivalent to clavulanic acid 6.25mg/mL |
| Dosage Form: | Powder for oral suspension |
| New Zealand Sponsor: | GlaxoSmithKline (NZ) Limited |
| Manufacturers: | SmithKline Beecham Pharmaceuticals Limited, Worthing, United Kingdom Glaxo Wellcome Production, Mayenne, France |
| Product: | Augmentin Forte |
| Active Ingredients: | Amoxicillin trihydrate 57.394mg/mL equivalent to amoxycillin 50mg/mL Potassium clavulanate 14.89mg/mL equivalent to clavulanic acid 12.5mg/mL |
| Dosage Form: | Powder for oral suspension |
| New Zealand Sponsor: | GlaxoSmithKline (NZ) Limited |
| Manufacturer: | Glaxo Wellcome Production, Mayenne, France |
| Product: | Fluconazole One |
| Active Ingredient: | Fluconazole 150mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Medreich New Zealand Limited |
| Manufacturer: | Adcock Ingram Limited – A Medreich Group Company, Bangalore, India |
| Product: | Maxiclear Chesty Cough |
| Active Ingredient: | Bromhexine hydrochloride 8mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | AFT Pharmaceuticals Limited |
| Manufacturer: | YSP Industries (M) Sdn. Bhd., Kajang, Malaysia |
| Product: | Medreich Fluconazole |
| Active Ingredient: | Fluconazole 150mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Medreich New Zealand Limited |
| Manufacturer: | Adcock Ingram Limited – A Medreich Group Company, Bangalore, India |
| Product: | Sirdupla DPI |
| Active Ingredients: | Fluticasone propionate 100mcg Salmeterol xinafoate 72.5mcg equivalent to salmeterol 50.0mcg |
| Dosage Form: | Powder for inhalation |
| New Zealand Sponsor: | Mylan New Zealand Limited |
| Manufacturer: | McDermott Laboratories Limited (t/a Mylan Dublin Respiratory), Dublin, Ireland |
| Product: | Sirdupla DPI |
| Active Ingredients: | Fluticasone propionate 250mcg Salmeterol xinafoate 72.5mcg equivalent to salmeterol 50.0mcg |
| Dosage Form: | Powder for inhalation |
| New Zealand Sponsor: | Mylan New Zealand Limited |
| Manufacturer: | McDermott Laboratories Limited (t/a Mylan Dublin Respiratory), Dublin, Ireland |
| Product: | Sirdupla DPI |
| Active Ingredients: | Fluticasone propionate 500mcg Salmeterol xinafoate 72.5mcg equivalent to salmeterol 50.0mcg |
| Dosage Form: | Powder for inhalation |
| New Zealand Sponsor: | Mylan New Zealand |
| Manufacturer: | McDermott Laboratories Limited (t/a Mylan Dublin Respiratory), Dublin, Ireland |
Dated this 8th day of May 2020.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).