Pursuant 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: | Duro-Tuss Chesty Cough Liquid Double Strength |
Active Ingredient: | Bromhexine hydrochloride 1.6mg/mL |
Dosage Form: | Oral solution |
New Zealand Sponsor: | iNova Pharmaceuticals (New Zealand) Limited |
Manufacturer: | Ensign Laboratories Pty Limited, Melbourne, Australia |
Product: | Ferro-Malt |
Active Ingredient: | Iron polymaltose 370mg equivalent to 100mg elemental iron |
Dosage Form: | Capsule |
New Zealand Sponsor: | AFT Pharmaceuticals Limited |
Manufacturer: | XL Laboratories Pvt. Limited, Bhiwadi, India |
Product: | Histaclear Soft Gel Caps (General Sale) |
Active Ingredient: | Cetirizine hydrochloride 10mg |
Dosage Form: | Soft gelatin capsule |
New Zealand Sponsor: | AFT Pharmaceuticals Limited |
Manufacturer: | XL Laboratories Pvt. Limited, Neemrana, India |
Product: | Histaclear Soft Gel Caps (Pharmacy Only) |
Active Ingredient: | Cetirizine hydrochloride 10mg |
Dosage Form: | Soft gelatin capsule |
New Zealand Sponsor: | AFT Pharmaceuticals Limited |
Manufacturer: | XL Laboratories Pvt. Limited, Neemrana, India |
Product: | Potassium Chloride 10 mmol in Sodium Chloride 0.9% (500 mL) |
Active Ingredients: | Potassium chloride 1.5mg/mL Sodium chloride 9mg/mL |
Dosage Form: | Solution for infusion |
New Zealand Sponsor: | Fresenius Kabi New Zealand Limited |
Manufacturers: | Labesfal Laboratories Almiro SA, Santiago de Besteiros, Portugal Fresenius Kabi Deutschland GmbH, Friedberg, Germany |
Product: | Potassium Chloride 20 mmol in Sodium Chloride 0.9% (1000 mL) |
Active Ingredients: | Potassium chloride 1.5mg/mL Sodium chloride 9mg/mL |
Dosage Form: | Solution for infusion |
New Zealand Sponsor: | Fresenius Kabi New Zealand Limited |
Manufacturers: | Labesfal Laboratories Almiro SA, Santiago de Besteiros, Portugal Fresenius Kabi Deutschland GmbH, Friedberg, Germany |
Product: | Potassium Chloride 20 mmol in Sodium Chloride 0.9% (500 mL) |
Active Ingredients: | Potassium chloride 3mg/mL Sodium chloride 9mg/mL |
Dosage Form: | Solution for infusion |
New Zealand Sponsor: | Fresenius Kabi New Zealand Limited |
Manufacturers: | Labesfal Laboratories Almiro SA, Santiago de Besteiros, Portugal Fresenius Kabi Deutschland GmbH, Friedberg, Germany |
Product: | Potassium Chloride 40 mmol in Sodium Chloride 0.9% (1000 mL) |
Active Ingredients: | Potassium chloride 3mg/mL Sodium chloride 9mg/mL |
Dosage Form: | Solution for infusion |
New Zealand Sponsor: | Fresenius Kabi New Zealand Limited |
Manufacturers: | Labesfal Laboratories Almiro SA, Santiago de Besteiros, Portugal Fresenius Kabi Deutschland GmbH, Friedberg, Germany |
Product: | Sugammadex Dr.Reddy’s (200mg/2mL) |
Active Ingredient: | Sugammadex sodium 108.8mg/mL equivalent to sugammadex 100mg/mL |
Dosage Form: | Solution for injection |
New Zealand Sponsor: | Dr Reddy’s New Zealand Limited |
Manufacturer: | Dr Reddy’s Laboratories Limited, Visakhapatnam, India |
Product: | Sugammadex Dr.Reddy’s (500mg/5mL) |
Active Ingredient: | Sugammadex sodium 108.8mg/mL equivalent to sugammadex 100mg/mL |
Dosage Form: | Solution for injection |
New Zealand Sponsor: | Dr Reddy’s New Zealand Limited |
Manufacturer: | Dr Reddy’s Laboratories Limited, Visakhapatnam, India |
Dated this 6th day of April 2023.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).