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: AdiraMedica Bromhexine
Active Ingredient: Bromhexine hydrochloride 8mg
Dosage Form: Tablet
New Zealand Sponsor: AdiraMedica Pty Limited
Manufacturer: Sunglow Lifescience Private Limited, Uthiramerur Taluk, India
   
Product: Chesty Cough
Active Ingredient: Bromhexine hydrochloride 8mg
Dosage Form: Tablet
New Zealand Sponsor: AdiraMedica Pty Limited
Manufacturer: Sunglow Lifescience Private Limited, Uthiramerur Taluk, India
   
Product: Codral Plus (Combination Product)
Active Ingredients: Paracetamol 500mg
Phenylephrine hydrochloride 5mg equivalent to phenylephrine 4.1mg
Dosage Form: Tablet
Active Ingredients: Benzocaine 10mg
Cetylpyridinium chloride 1.47mg equivalent to cetylpyridinium chloride anhydrous 1.4mg
Dosage Form: Lozenge
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturers: Unique Pharmaceuticals Laboratories, Nani Daman, India
Probiotec Pharma Pty Limited, Melbourne, Australia
   
Product: Glycoprep Orange
Active Ingredients: Macrogol 3350 52.9g
Potassium chloride 0.74g
Sodium chloride 2.6g
Sodium sulfate 5.6g
Dosage Form: Powder for oral solution
New Zealand Sponsor: Fresenius Kabi New Zealand Limited
Manufacturer: Probiotec Pharma Pty Limited, Melbourne, Australia
   
Product: Selsun Gold
Active Ingredient: Selenium sulfide 25mg/mL
Dosage Form: Shampoo
New Zealand Sponsor: Sanofi-Aventis New Zealand Limited
Manufacturer: Pax Australia Pty Limited, Sydney, Australia
   
Product: Spironolactone
Active Ingredient: Spironolactone 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Max Health Limited
Manufacturers: Intas Pharmaceuticals Limited, Ahmedabad, India
Intas Pharmaceuticals Limited, Dehradun, India
   
Product: Spironolactone
Active Ingredient: Spironolactone 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Max Health Limited
Manufacturers: Intas Pharmaceuticals Limited, Ahmedabad, India
Intas Pharmaceuticals Limited, Dehradun, India


Dated this 20th day of July 2021.

CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).