Notice Type
Departmental
Notice Title

Consent to the Distribution of New Medicines

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).