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:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Apo-Rizatriptan
Rizatriptan benzoate 7.265mg equivalent to rizatriptan 5mg
Orodispersible tablet
Apotex NZ Limited
Apotex Research Private Limited, Bangalore, India

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Apo-Rizatriptan
Rizatriptan benzoate 14.53mg equivalent to rizatriptan 10mg
Orodispersible tablet
Apotex NZ Limited
Apotex Research Private Limited, Bangalore, India

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Microshield 2 Chlorhexidine Skin Cleanser
Chlorhexidine gluconate 2%w/v
Topical solution
Schulke New Zealand Limited
Ensign Laboratories Pty Limited, Melbourne, Australia

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Moxifloxacin-Claris
Moxifloxacin hydrochloride 1.74mg/mL equivalent to moxifloxacin 1.60mg/mL
Solution for infusion
Baxter Healthcare Limited
Claris Injectables Limited, Ahmedabad, India

Product:
Active Ingredients:


Dosage Form:
New Zealand Sponsor:
Manufacturer:

Mylanta Antacid Double Strength
Aluminium hydroxide 80mg/mL
Magnesium hydroxide 80mg/mL
Simethicone 6mg/mL as 20mg/mL of simeticone emulsion Q7-2587 30%
Oral suspension
Johnson & Johnson (New Zealand) Limited
Ensign Laboratories Pty Limited, Melbourne, Australia

Product:
Active Ingredients:


Dosage Form:
New Zealand Sponsor:
Manufacturer:

Mylanta Antacid Original
Aluminium hydroxide 40mg/mL
Magnesium hydroxide 40mg/mL
Simethicone 4mg/mL as 17.3mg/mL of simethicone emulsion Q7-2587 30%
Oral suspension
Johnson & Johnson (New Zealand) Limited
Ensign Laboratories Pty Limited, Melbourne, Australia

Dated this 31st day of July 2018.

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